6 research outputs found
Looking at calcimimetics impact on hypercalcemia of immobilization: Hypotheses and a case study
- Author
- Publication venue
- 'Wiley'
- Publication date
- Field of study
Low incidence of SARS-CoV-2, risk factors of mortality and the course of illness in the French national cohort of dialysis patients
- Author
- Abbade Mohamed Adnan
- Abbassi Abdelhamid
- Abd El Fatah Mohamed Abo Bakr
- Abokasem Ayman
- Aboubekr Habib
- Abtahi Mahdi
- Acamer Sophie
- Achiche Jedjiga
- Adda Hassen
- Adem Arezki
- Adra Anne Laure
- Afiani Aida
- Agbonon Ekoue
- Aglae Violaine Emal
- Aguilera Didier
- Aizel Ali
- Akposso Kodso
- Al Morabiti Mustapha
- Aladib Mohamed
- Albadawy Mahen
- Albaret Julie
- Albert Catherine
- Aldigier Jean Claude
- Allal Asma
- Allal Radia
- Allot Vincent
- Almoubarak Imad
- Alouach Mahmoud
- Alphonse Jean Claude
- Alrifai Assem
- Amani Francois Roux
- Amaouche Amar
- Amara Brahim
- Amaria Rachid
- Amirou Mustapha
- Ammar Naji
- Ammor Mounia
- Amrandi Mokhtar
- Aneni Wided Tabbi
- Aoun Bilal
- Araujo Caroline
- Argiles Angel
- Arnautou Jean
- Atchia Hafsabhai
- Attias Julie Sohier
- Attias Philippe
- Aubertin Perrine
- Ayav Carole
- Azar Raymond
- Azoulay Eric
- Azzouz Lynda
- Babici Daniela
- Babinet Francois
- Bacchetta Justine
- Bacri Jean Louis
- Badid Cherif
- Badulescu Viorica
- Baillet Anabelle
- Balde Mamadou
- Baleynaud Juliette
- Balit Gabriel
- Ball Beatrice
- Baluta Simona
- Baranger Thierry
- Barbier Stephane
- Bargas Evelyne
- Baron Cecile Turc
- Baron Emmanuel
- Baron Maurice
- Barsumau Joseph
- Basse Francois
- Bassilios Nader
- Basteri Michel
- Bataille Pierre
- bataille stanislas
- Batho Jean Marie
- Bayer Florian
- Bazin Dorothee
- Beau S.
- Beauchamp Christine
- Beaudoin Agnes Caillette
- Beaudreuil Severine
- Beaume Julie
- Becart Jacques
- Belhadj Ihssen
- Bellahsene Farid
- Bellenfant Xavier
- Bellhasene Farid
- Bellou Moufida
- Belmouaz Mohamed
- Ben Ahmed Adel
- Benabid Zaid
- Benalia Hadjira
- Benarbia Seddick
- Benbrahim Oussamah Fikri
- Bencheikh Larbi
- Bendini Jean Christophe
- Benhabib Tassadit
- Benmoussa Abdelatif
- Bennini Chaouki
- Bensalem Tayeb
- Bensman Albert
- Benyaghla Sidi Ali
- Benzakour Mountassir
- Berard Etienne
- Berge Franck
- Bernard Claude
- Bertaux Martine
- Bertrand Dominique
- Besnier Dominique
- Bessenay Lucie
- Bessin Catherine
- Besson Frederic
- Besson Virginie
- Bidault Caroline
- Bijak Krzysztof
- Billion Stephane
- Binaut Reynald
- Bindi Pascal
- Bittar Haiat
- Blanchier Dominique
- Bobrie Guillaume
- Bocquentin Frederique
- Boissinot Lucie
- Bonarek Herve
- Boncila Simona
- Bonnard Guillaume
- Bonne Jean Francois
- Bonniol Claude
- Borde Jean Sebastien
- Bosc Jean Yves
- Bouachi Khedidja
- Bouaka Christophe
- Boubenider Samir
- Boubia Toufik
- Boubia Veronique
- Bouchet Jean Louis
- Bouchoule Isabelle
- Boudemaghe Thierry
- Boudet Remi
- Boudi Wael
- Bougrida Hammouche
- Bouiller Marc
- Boukadida Amine
- Boukelmoune Maklouf
- Boukerroucha Zacharia
- Boukhalfa Zohra
- Boula Aime Remy
- Boulahia Ghada
- Boulahrouz Rehouni
- Boulanger Henri
- Boulechfar Hacene
- Boullenger Fanny
- Boumendjel Nourredine
- Bourdenx Jean Philippe
- Bourdon Franck
- Bourgeon Bruno
- Bourouma Rachid
- Boury Edouard
- Boustani Rafaat
- Bouvier Nicolas
- Bouzar Lilia Antri
- Bouzernidj Mouloud
- Brahim Mohamed
- Brahimi Mabrouk
- Brasseur Jose
- Bridoux Franck
- Briffa Dominique
- Brignon Pierre
- Brillet Georges
- Brocard Jean
- Broux Francoise
- Bruckmann Niels
- Brunak Yvan
- Brunet Philippe
- Bruno Danielle
- Bugnon Denis
- Bulte Francoise
- Burbach Maren
- Béchade Clémence
- Caillard Pauline
- Calonge Victorio Menoyo
- Caniot Elisabeth
- Canivet Eric
- Cantin Jean Francois
- Capdeville Arthur
- Cardon Gerard
- Cardozo Jorge
- Carolfi Jean
- Carre Assia Ferhat
- Carron Pierre Louis
- Cartou Charles
- Castellano Ines
- Castin Nelly
- Castrale Cindy
- Catoliquot Marie Noelle
- Caudwell Valerie
- Caux Dominique
- Cazajous Geraldine
- Cazin Marie Cecile
- Chabannier Marie Helene
- Chaghouri Baher
- Chaigne Virginie
- Chalabi Lotfi
- Chalmin Florence
- Chalopin Jean Marc
- Champion Gerard
- Champion Laure
- Chanas Monique
- Chantrel François
- Chapelet Arielle
- Charasse Christophe
- Chargui Soumaya
- Charles Jacques Ibsen
- Charlin Emmanuelle
- Chatelet T.
- Chatelet Valerie
- Chauveau Philippe
- Chauvet Sophie
- Chawki Mokhtar
- Chazot Charles
- Chedid Khalil
- Chenine Leila
- Cherif Mohamed Fodil
- Chlih Bouchra
- Chong Michel Fen
- Choukroun Gabriel
- Chuet Christian
- Ciobotaru Monica
- Citarda Salvatore
- Clabault Karine
- Clair Francois
- Claudeon Joelle
- Cledes Jacques
- Clement Guillaume
- Cloarec Sylvie
- Cluzel Pascal
- Coevoet Bruno
- Coindre Philippe
- Coldefy Olivier
- Colombo Alexandra
- Combarnous François
- Combe Christian
- Corne Benedicte Hodemon
- Coste Didier
- Coste Philippe
- Couchoud Cécile
- Coudert Krier Marie Jeanne
- Coulibaly Jean Marie
- Coulibaly Moussa
- Coulomb Francois
- Coupel Stephanie
- Cousin Maud
- Cremault Alain
- Creput Caroline
- Cristescu Diana Istrati
- Crougneau Valerie
- Croze Laure
- Cuny Melodie
- Cuvelier Rene
- D'ythurbide Geraldine
- Dabot Christian
- Dahmane Djamal
- Dahmoune Said
- Daniliuc Ioana
- Dardim Karim
- Dargelos Mathilde
- Darie Ioana
- Daroux Maite
- Daubresse Daniel
- Daugas Eric
- David Daniela
- De Cornelissen Francois
- De Fremont Jean Francois
- De Marion Gaja Catherine
- De Martin Alfio
- De Precigout Valerie
- De Preneuf Helene
- De Ste Foy Celia Lessore
- Debout Agnes Chapelet
- Debure Alain
- Dehay Julien
- Del Bello Arnaud
- Delattre Vincent
- Delaval Ronan
- Delavaud Guy
- Delbes Sebastien
- Delbet Jean Daniel
- Delclaux Caroline
- Deleaval Patrik
- Delezire Arnaud
- Delmas Yahsou
- Delvallez Luc
- Demontis Renato
- Depraetre Pascale
- Deprele Carole
- Deroure Benjamin
- Dervaux Thomas
- Deschenes Georges
- Deschodt Gerard
- Desport Estelle
- Dessassis Jean Francois
- Desvergnes Claude
- Desvergnes Gregoire Couvrat
- Deteix Patrice
- Detourne Cindy
- Devaux Jean Philippe
- Devriendt Isabelle
- Dhib Malek
- Diab Raji
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- Diant Marlene Beaubrun
- Diarrassouba Assetou
- Dickson Zara
- Diddaoui Ali Zineddine
- Diet Carine
- Dimitrov Yves
- Dimulescu Radu
- Dimulescu Theodora
- Dincu Daniela
- Diolez Jeremie
- Dion Jean Jacques
- Diouani Mohamed
- Dirhold Caroline Preissig
- Dita Camelia Ghiciuc
- Djeffal Rachid
- Djelaleddine Benyakoub
- Djema Assia
- Djiconkpode Irenee
- Donnadieu Patrick
- Doussy Yves
- Drouillat Valerie
- Drouineau Olivier
- du Halgouet Caroline
- Dubau Malina
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- Dubot Philippe
- Dubrasquet Astrid Godron
- Ducros Jacques
- Dufay Alexandre
- Duflot Laurent
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- Dufresne Roger
- Duhem Alexandra
- Dumont Genevieve
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- Dumoulin Madeleine
- Dunand Olivier
- Duneau Gabrielle
- Dupont Philippe Martin
- Dupuis Clémentine
- Dupuis Emmanuel
- Duquennoy Simon
- Duquesne Alyette
- Durand Dominique
- Durand Pierre Yves
- Duval Sophie Rubens
- Duvic Christian
- Duvic Jacques
- Ebel Alexandre
- Ebikili Bertin
- El Ali Hamid
- El Amari Abderrahim
- El Esper Najeh
- El Haggan Wael
- El Kaeoui Khalil
- El Karoui Khalil
- El Nasser Khuzama
- Elmrabet Atman Haddj
- Emond Christian
- Enache Ioana
- Eprinchard Laure
- Erbilgin Dilaver
- Erina Torres Pablo Antonio
- Esposito Miguel
- Essi Marie
- Eugene Marc
- Fache Emilie
- Faller Anne Laure
- Falque Veronique
- Fat Maeva Wong
- Faucher Justine
- Faucon Jean Paul
- Favennec Caroline
- Fedorca Ana
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- Ferrandiz Ines
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- Fickl Rocsana
- Fievet Patrick
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- Filipozzi Pierre
- Finielz Paul
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- Fohrer Patrick
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- Fourcade Jacques
- Fournier Alain
- FOURNIER Albert
- Fournier Philippe
- Fournier Veronique
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- Francois Maud
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- Freguin Caroline
- Freist Marine
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- Fromentin Luc
- Fumeron Christine
- Gaboriau Elke
- Gabriel Jean Marc
- Galantine Valerie
- Galland Roula
- Gamberoni Joel
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- Garnier Fabrice
- Garrouste Cyril
- Gaudry Xavier Moreau
- Gaultier Jacques
- Gauthier Eric
- Gauthier Marion
- Gavard Marie Sophie
- Gbindoun Ubald Assogba
- Ged Etienne
- Genestier Sandrine
- Genin Robert
- Georgieva Lora
- Gerard Fabien
- Ghali Nasredine
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- Gheerbrandt J. Dominique
- Ghemmour Amel
- Gilbert Olivia
- Gilson Brigitte
- Giorgita Ancuta Bouffandeau
- Giraud Patrick
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- Glowacki Francois
- Godart Catherine
- Golea Gabriella
- Gouin Jean Baptiste
- Goumri Nabila
- Goupy Christophe
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- Gruget Gabriel
- Guenifi Ismahane
- Guerard Arnaud
- Gueret Claudine
- Guergour Mounir
- Guerraoui Abdallah
- Guerrot Dominique
- Guery Bruno
- Gueuttin Victor
- Guiard Elsa
- Guibergia Corinne
- Guillodo Marie Paule
- Guillon Wen Qin
- Guincestre Thomas
- Guiraud Cecile
- Guiserix Jose
- Hachicha Mourad
- Hacini Sabria
- Hacq Bertrand
- Haddad Imad
- Hadj Abdelkader
- Hafi Ali
- Hafi Aline
- Haidar Fadi
- Halin Pascale
- Hallonet Patrick
- Hamani Abdelaziz
- Hamdini Nasser
- Hamel Didier
- Hammelin Jean Philippe
- Hanafi Latifa
- Hanf William
- Hannaert Marie Claude
- Hannedouche Thierry
- Hanoy Melanie
- HARAMBAT Jerome
- Harbouche Laid
- Hardin Jean Michel
- Harrami Elarbi
- Haskour Ibrahim
- Haultier Jean Jacques
- Haussaire Delphine
- Hazzan Marc
- Hebibi Hadia
- Hecht Michel
- Hecquet Emmanuelle
- Heibel Francoise
- Hemery Michele
- Henaoui Bachir
- Heng Anne Elisabeth
- Henri Patrick
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- Hiernaux Philippe
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- Housset Pierre
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- Hue Patricia
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- Hurot Jean Marc
- Ikonga Donatien
- Imhoff Olivier
- Imiela Jean Paul
- Indrieis Monica
- Ingwiller Maxime
- Islam Mohamed Sharifull
- Ismer Manfred
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- Jamali Mohamed
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- Servel Marie France
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- Sirajedine Khaled
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- Taddei Catherine
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- Vigeral Philippe
- Vilaine Eve
- Villar Emmanuel
- Villemain Florence
- Viprey Delphine Henriet
- Viron Beatrice
- Virot Jean Simon
- Visanica Dorina
- Vitanova Lorita
- Vittoz Nathalie
- Viviani Veronique
- Von Ey Friederike
- Von Kotze Clarissa
- Vrigneaud Laurence
- Vrillon Isabelle
- Wajsbrot Lucie
- Wauquier Jean Pierre
- Weclawiak Hugo
- Wehbe Bassem
- Weis Lise
- Westeel Pierre Francois
- Wheatley Pascal
- Wiart Geraldine Robitaille
- Wong Tony
- Wuillai Anne
- Yazbeck Fatima
- Yazji Jamal
- Yousfi Kamel
- Yue Wah Philippe Lan
- Yverneau Paule Hardy
- Zaidi Hocine
- Zanetta Gilbert
- Zannier Alfredo
- Zaoui Philippe
- Ziane Abdelaziz
- Zins Brigitte
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/12/2020
- Field of study
International audienceThe aim of this study was to estimate the incidence of COVID-19 disease in the French national population of dialysis patients, their course of illness and to identify the risk factors associated with mortality. Our study included all patients on dialysis recorded in the French REIN Registry in April 2020. Clinical characteristics at last follow-up and the evolution of COVID-19 illness severity over time were recorded for diagnosed cases (either suspicious clinical symptoms, characteristic signs on the chest scan or a positive reverse transcription polymerase chain reaction) for SARS-CoV-2. A total of 1,621 infected patients were reported on the REIN registry from March 16th, 2020 to May 4th, 2020. Of these, 344 died. The prevalence of COVID-19 patients varied from less than 1% to 10% between regions. The probability of being a case was higher in males, patients with diabetes, those in need of assistance for transfer or treated at a self-care unit. Dialysis at home was associated with a lower probability of being infected as was being a smoker, a former smoker, having an active malignancy, or peripheral vascular disease. Mortality in diagnosed cases (21%) was associated with the same causes as in the general population. Higher age, hypoalbuminemia and the presence of an ischemic heart disease were statistically independently associated with a higher risk of death. Being treated at a selfcare unit was associated with a lower risk. Thus, our study showed a relatively low frequency of COVID-19 among dialysis patients contrary to what might have been assumed
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- Abbasciano  Isabella
- Abrantes  Catarina
- Accarino  Simone
- Adler  Sharon
- Adoberg  Annika
- Afsari  Rouzbeh
- Ahmad  Syeda
- Ahmed  Jafar
- Ahn  Wooin
- Ajayi  Bamidele
- Aksamit  Dariusz
- Al Chalabi  Saif
- Alamartine  Eric
- Alchi  Bassam
- Ali  Mohammad
- Aliotta  Roberta
- Almaani  Salem
- Almeida  Catarina
- Almeida  Edgar
- Alpers  Charles E
- Alvarez  Francisco de la Prada
- Alves  Patricia
- Annese  Francesca
- Appel  Gerald
- Arduan  Alberto Ortiz
- Arena  Maria
- Arevalo  Marta Calvo
- Arfaania  Dariush
- Arias  Carlos
- Aristoy  Emma Calatayud
- Asakiene  Egle
- Ashley  Sarah
- Assefi  Ali
- Atenza  Alba
- Auerbach  Asta
- Augustyniak-Bartosik  Hanna
- Avella  Monroy
- Ayling-Smith  Jonathan
- Ayoub  Isabelle
- Ayvazyan  Christine
- Baccaro  Rocco
- Bailey  Asha
- Baker  Bruce
- Balamuthusamy  Saravanan
- Ballarin  Jose
- Barata  Rui
- Barbic  Jerko
- Barisic  Dunja
- Barratt  Jonathan
- Barreto  Jose Carlos de Jesus
- Barrios  Clara
- Belingheri  Mirco
- Benesova  Anna
- Bernabeu  Ana Avila
- Bernhardt  Wanja
- Bhadra  Shamik
- Biancone  Luigi
- Bieler  Stewart
- Blanchard  Anne
- Boaglio  Elena
- Bolignano  Davide
- Bomback  Andrew
- Bonilla  Gustavo Andres Useche
- Bordoli  Monica
- Bose  Bhadran
- Boudville  Neil
- Brandon  Donald
- Brown  Karen
- Broyet  Christian
- Bucknall  Thomas
- Buffet  Alexandre
- Bumblyte' Â Inga Arune
- Burdese  Manuel
- Burgos  Natalia Allende
- Burguet  Laure
- Burtey  Stephane
- Busch  Martin
- Cakiroglu  Figen
- Campbell  Victoria
- Canetta  Pietro
- Capaccio  Flavia
- Carbonell  Juan
- Cardoso  Filipa
- Carro  Clara Garcia
- Carroll  Robert
- Carron  Pierre-Louis
- Carullo  Nazareno
- Cassia  Matthias
- Caster  Dawn
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- Chakera  Aron
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- Chan  Doris
- Chan  Gary Chi Wang
- Chan  Lai Wan
- Chang  Jae Hyun
- Chang  Ming-Shan
- Chapman  Fiona
- Charytan  Chaim
- Chaudhry  Asghar
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- Chen  Chien-Liang
- Chen  Hsin-Yu
- Chen  Hung-Chun
- Chen  Hung-Yuan
- Chenine  Leila
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- Cheung  Siu Fai
- Chiche-Jourde  Noemie
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- Chiu  Ian
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- Chiu  Yi-Wen
- Choi  Hoon Young
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- Chowdhury  Paramit
- Chowdhury  Pradip
- Chrysochou  Constantina
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- Cieniawski  Dominik
- Claisse  Guillaume
- Clayton  Philip
- Cleary  Catalina MartÃn
- Clement  Nisha
- Coates  Toby
- Cogno  Chiara
- Colla  Loredana
- Collins  Michael
- Colucci  Marco
- Combe  Christian
- Comi  Nicolino
- Comunale  Roderick
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- Cooper  Bruce
- Coppock  Gaia
- Costa  Ana Cortesão
- Costanzi  Stefano
- Cozzolino  Mario
- Crail  Susan
- Cunha  Liliana
- Curry  Elizabeth
- Dai  Tiane
- Daina  Erica
- Daneshvari  Sam
- Dasgupta  Indranil
- DaSilva  Louise
- Davidson  Robert
- De Bhailis  Aine Maire
- de Précigout  Valérie
- Decupere  Marc
- Delmas  Yahsou
- Deodato  Francesca
- Dhaun  Neeraj
- Dhaygude  Ajay
- Dhelaria  Ranjit
- Di Maio  Federica
- Diezhandino  Maria Angeles Goicoechea
- Dika  Zivka
- Dinic  Miriana
- Dittmer  Ian
- Diva  Ulysses A
- Dobre  Mirela
- Doctor  Gabriel
- Donati  Gabriele
- Doubel  Peter
- Douthit  Nicole
- Draganova  Diliana
- Drexler  Yelena
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- Drinovska  Klara
- Dudreuilh  Caroline
- Dumond  Clement
- Durlen  Ivan
- Dussol  Bertrand
- Encarnacion  Montserrat Diaz
- Endre  Zoltan
- Enrique  Jorge
- Eqbal  Yusuf
- Erlich  Jonathan
- Esposito  Ciro
- Esposito  Vittoria
- Fakih  Faisal
- Fang  Hua-Chang
- Farinha  Ana
- Fearday  Aaron
- Felgueiras  Joana de Sousa Soares
- Felicjanczuk  Elzbieta
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- Fernandes  João Carlos
- Fernandes  Sara
- Fernandez  Jose Luño
- Fernandez  Victor
- Fernando  Mangalee
- Figueiredo  Ana Carolina
- Firre  Eric
- Floege  Jürgen
- Flossmann  Oliver
- Floyd  Lauren
- Fonseca  Jose Nuno de Almeida Agapito
- Fonseca  Nuno
- Foote  Celine
- Forbes  Suzanne
- Forcen  Angel
- Fornoni  Alessia
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- Fung  Ka Shun Samuel
- Furlano  Monica
- Furtado  Teresa
- Gadh  Rajdeep
- Gaisset  Roxane
- Gallagher  Martin
- Gameiro  Joana
- Gangadharan  Muralikrishna
- Garcia  Fabiola Alonso
- Garcia  Olga Gracia
- Garg  Gunjan
- Garrouste  Cyril
- Gautam  Archana
- Geara  Abdallah
- Geddes  Colin
- Gellineo  Lana
- Germain  Michael
- Gesualdo  Loreto
- Ghalli  Farid
- Giaroni  Francesco
- Giles  Harold
- Gillies  Alastair
- Gimeno  Ana Vilar
- Girardet  Annette
- Glaze  Jeffrey
- Goh  Tze
- Gois  Mario
- Goldsmith  Christopher
- Goma  Elena
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- Goncalves  Sara
- Gontarek-Kacprzak  Julita
- Gonzalez  Carlos
- Gopu  Arun
- Gowda  Nayan
- Gray  Nicholas
- Greco  Barbara
- Green  Heather
- Greze  Clarisse
- Griffin  Sian
- Guldris  Secundino Cigarran
- Guzman  Ursula Verdalles
- Ha  Jeffrey Tsun Kit
- Hall  Amanda
- Hamilton  Patrick
- Han  Seung Hyeok
- Haws  Robert
- Hayat  Ashik
- Heath  Lauren
- Heerspink  Hiddo J L
- Heinrichs  Sven
- Henderson  Amy
- Henderson  Andrew
- Hendren  Elizabeth
- Heng  Anne-Elisabeth
- Heres  Salia Virxinia Pol
- Herfurth  Johann Konstantin
- Herrero  Evangelina Merida
- Ho  Tzung-Yo
- Hogan  Jonathan
- Hohenstein  Bernd
- Hollett  Peter
- Horvatic  Ivica
- Hsu  Bang-Gee
- Hsu  Chia-Tien
- Hsu  Chih-Yang
- Hsu  Shih-Ping
- Huang  Chien-Wei
- Hudson  Amy
- Hung  Chi-Chih
- Hwang  Daw-Yang
- Hwang  Shang-Jyh
- Hyun  Young Youl
- Ilmoja  Madis
- Inrig  Jula K
- Irish  Georgina
- Jacob  Radu
- Jahan  Sadia
- Jain  Arunima
- Jamar  Sofie
- Jander  Anna
- Jang  Hye Ryoun
- Janko  Catherine
- Jardine  Meg
- Jaskowski  Piotr
- Jeantet  Guillaume
- Jelakovic  Bojan
- Jeon  Junseok
- Jeong  Jong Cheol
- Jesudason  Shilpanjali
- Jittirat  Arksarapuk
- Jo  Sang-Kyung
- Jones  Rachel
- Joo  Narae
- Jorge  Sofia
- Julian  Bruce
- Jung  JiYong
- Jyothinagaram  Praveena
- Kadakia  Jigar
- Kamal  Fahameedah
- Kanigicherla  Durga
- Karanovic  Sandra
- Karras  Alexandre
- Kasimatis  Theodoros
- Kassem  Mohamad
- Kattamanchi  Siddhartha
- Keller  Christopher
- Kentric  Dubravka Trajbar
- Kettner  Christiane
- Khalil  Kassem
- Kim  Aejin
- Kim  Dana
- Kim  Hyung Wook
- Kim  Jwa-Kyung
- Kim  Myung-Gyu
- Kim  Se Joong
- Kim  Sunggyun
- Kim  Yeong Hoon
- Kim  Yunmi
- Kimber  Cassandra
- Klamm  Kathryn
- Koch  Annegret
- Koester  Eric
- Kohan  Donald E
- Kolvald  Kulli
- Komers  Radko
- Kon  Sui
- Kooienga  Laura Ann
- Kotwal  Sradha
- Krajewska  Magdalena
- Kratka  Karolina
- Krishnan  Anoushka
- Krishnasamy  Rathika
- Krueger  Thilo
- Kruljac  Ivan
- Kulka  Simone
- Kunzendorf  Ulrich
- Kuo  Hung-Tien
- Kuo  Mei-Chuan
- Kuo  Sheng
- Kwan  Lorraine Pui Yuen
- Kwella  Bogna
- Kwella  Norbert
- Kyaw  Kay
- Labat  Aurore
- Lafayette  Richard
- Lagatta  Mark
- Lam  Chi Kwan Darwin
- Lambie  Mark
- Lanaret  Camille
- Latif  Farah
- Laute  Margo
- Law  Wai Ping
- Lawman  Sarah
- Lazo  Mercedes Salgueira
- Lee  Hajeong
- Lee  Hyun Hee
- Lee  Hyung-seok
- Lee  JungEun
- Lee  Kyu-Beck
- Lee  Moon Hyoung
- Lee  Po-Tsang
- Leis  Liisi
- Lemahieu  Wim
- Leung  Janson
- Li  Yan
- Lie  Davina Ngoi Wah
- Lifland  Howard
- Lilienthal  Kadri
- Lim  Wai
- Limardo  Monica
- Livrozet  Marine
- Longhi  Selena
- Lopes  Daniela
- Lopes  Jose Antonio
- Lorde  Nathan
- Luxton  Grant
- Ma  Mingyao
- Madhrira  Machaiah
- Madonia  Phillip
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- Mahdi  Amar
- Mahdi  Eamon
- Maillard  Nicolas
- Maixnerova  Dita
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- Malecki  Robert
- Malfait  Thomas
- Malvica  Silvia
- Mandayam  Sreedhar
- Manley  Paul
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- Marcantoni  Carmelita
- Mariat  Christophe
- Marin  Lida Maria Rodas
- Marin  Tamara Malek
- Mark  Patrick
- Marques  Joana
- Martinez  Eduardo Gutierrez
- Martinez  Stacy
- Masset  Catherine
- Masson  Ingrid
- Mather  Amanda
- Maung Myint  Thida Maung
- Mayet  Valentin
- Małecki  Robert
- McCafferty  Kieran
- McCarthy  Ellen
- McDonald  Stephen
- McGreal  Kerri
- McMahon  Kellyn
- McNally  Andrew
- McQuarrie  Emily
- Medina  Allyson
- Meeus  Gert
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- Menezes  Maria
- Meng  Jerry
- Mercer  Alex
- Messa  Piergiorgio
- Messias  Ana
- Miarka  Przemyslaw
- Miglinas  Marius
- Mikacic  Ivana
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- Milicevic  Martina
- Minasian  Raffi
- Moeller  Marcus
- Mohey  Hesham
- Mojarrab  Javad
- Mok  Maggie Ming Yee
- Moncasi  Eduardo Parra
- Moonen  Martial
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- Moreno  Antolina
- Moreno  Eduardo Verde
- Morris  Adam
- Moutzouris  Dimitrios
- Moya  Mercedes Gonzalez
- Mucha  Simon
- Musolino  Michela
- Napodano  Pietro
- Natario  Ana
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- Neuen  Brendon
- Newsome  Britt
- Ng  Kit Chung Jack
- Nguyen  Thu
- Nguyen  Viet
- Nicolo  Clementine
- Nitschke  Martin
- Noble  Euan
- Nolasco  Fernando
- Noronha  Irene L
- O'Lone  Emma
- O'Shaughnessy  Michelle
- Ochoa  Adriana Sierra
- Oh  Kook-Hwan
- Oh  Se Won
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- Papadia  Federica
- Pardinhas  Clara
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- Parikh  Samir
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- Park  Jung Tak
- Parreira  Lucia
- Passerini  Patrizia
- Patak  Ramachandra
- Patecki  Margret
- Patel Suthar  Meera
- Patel  Jusmin
- Patel  Rajan
- Patella  Gemma
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- Paxton  William
- Peh  Chen
- Peh  Chen Au
- Peleg  Yonatan
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- Perez de Jose  Ana
- Perez Lluna  Leticia
- Perez  Erika
- Perez  Jonay Pantoja
- Peri  Usha
- Perico  Norberto
- Perkovic  Vlado
- Philipponnet  Carole
- Phua  Elaine
- Piel  Julia
- Pillai  Unnikrishnan
- Pilmore  Helen
- Plavljanic  Djuro
- Plaza  Mercedes Velo
- Pollock  Carol
- Ponnusamy  Arvind
- Ponti  Serena
- Powell  Thomas
- Pradhan  Nishigandha
- Prado  Raul Fernandez
- Praga  Manuel
- Preciado  Priscila
- Prkacin  Ingrid
- Pruthi  Rishi
- Pugh  Dan
- Pérez Gómez  MarÃa Vanessa
- Quinn  Sarah
- Quintana  Luis F
- Raakesh  Lathika
- Rabindranath  Kannaiyan
- Radermacher  Luc
- Radhakrishnan  Jai
- Ragy  Omar Sherin Ibrahim
- Raichoudhury  Ritesh
- Raimundo  Mario
- Randone  Paolo
- Razavian  Mona
- Reichel  Helmut
- Reis  Marina
- Remuzzi  Giuseppe
- Reynolds  Annie
- Rheault  Michelle N
- Ricchiuto  Anna
- Rico  Ivon Maritza Bobadilla
- Rigothier  Claire
- Ritchie  Angus
- Rivero  Maria Antonieta Azancot
- Rizk  Dana
- Ro  Han
- Rodriguez Garcia  Eva
- Rodriguez  Alfred
- Roger  Simon
- Rony  Mohammad
- Rosenberg  Mai
- Rote  William E
- Roueff  Stephane
- Rovin  Brad
- Rovin  Brad H
- Roxburgh  Sarah
- Ruiz  Mario
- Rusinol  Helena Marco
- Rychlik  Ivan
- Salehi  Tania
- Sanden  Silja
- Santockiene  Lina
- Santos  Iara Da Silva
- Santos  Patricia Valerio
- Sargsyan  Mari
- Sarnow  Franziska
- Sat  Sebahat
- Satora  Ewa
- Savuk  Ana
- Sayer  Matthew
- Schlieper  Georg
- Schlosser  Mandy
- Schmidt-Guertler  Hans
- Schockaert  Olivier
- Schulte  Kevin
- Schulz  Lisa
- Selvaskandan  Haresh
- Semple  David
- Sen  Shaundeep
- Seppet  Elviira
- Serrano  Antonio Galan
- Serre  Jean-Emmanuel
- Sevillano  Angel
- Shah  Sapna
- Shen  Yvonne
- Sheridan  Brittany
- Shu  Kai-Hsiang
- Sightler  Ford
- Silva  Arnold
- Silva  Sónia
- Sinha  Smeeta
- Siriwardana  Amanda
- Sitas  Zvonimir
- Sivo  Carmen
- Sizeland  Peter
- Sly  Cathylee
- Smith  Priscilla
- Snow  Brian
- Soares  Elsa Sofia Quadrado
- Solazzo  Andrea
- Solis  Elena Gutierrez
- Solomon  Laurence
- Song  Young Rim
- Sousa  Helena
- Spinowitz  Bruce
- Stallworthy  Elizabeth
- Stamellou  Eleni
- Stanczyk  Malgorzata
- Stangenberg  Stefanie
- Stankovic  Marija
- Stankuviene  Asta
- Stea  Emma Diletta
- Stompor  Tomasz
- Storrar  Joshua
- Sullivan  James
- Sulowicz  Wladyslaw
- Suyumova  Irina
- Szeto  Cheuk Chun
- Sá  Helena
- Sánchez de la Nieta  Maria Dolores
- Tamarit  Esther
- Tan  Eddie
- Tan  May
- Tang  Hon
- Tang  Sydney C W
- Tang  Sydney Chi Wai
- Teixeira  Catarina
- Telling  Kadri
- Terrades  Natalia Ramos
- Tesar  Vladimir
- Tez  Didem
- Thervet  Eric
- Thibaudin  Damien
- Thomas  Mark
- Thyagarajan  Nikhil
- Tkaczyk  Marcin
- Torreggiani  Massimo
- Trachtman  Howard
- Trillini  Matias
- Trimarchi  Hernán
- Tsai  Jer-Chia
- Tsai  Shang-Feng
- Tsai  Wan-Chuan
- Tseng  Po-Yu
- Tumlin  James
- Tumlin  James A
- Tung  Kuei-Ting
- Turnbull  Angus
- Udani  Suneel
- Uhlinova  Jana
- Unt  Kristin
- Urciuolo  Federica
- Vanacker  An
- Vandewiele  Bert
- Vaz  Alvaro
- Veermae  Kristi
- Viaene  Liesbeth
- Vickiene  Alvita
- Vigano  Sara
- Vila  Maria Antonia Munar
- Vilayur  Eswari
- Villanueva  Caridad Martinez
- Villarroya  Cristina Medrano
- Villen  Alejandro Soria
- Viramontes  Veronica
- Vita  Caterina
- Vujcic  Dunja
- Wahba  Mona
- Wan  Susan
- Wang  Chih-Hsien
- Warling  Xavier
- Waters  Gerald
- Waugh  Jane
- Weiland  Lea
- Weiner  Stefan
- Weinreich  Thomas
- Werth  Stephan Christian
- Wickens  Olivia
- Wijeratne  Vidu
- Wilder  Karen
- Willcocks  Lisa
- Williams  Allister
- Winiarska  Agata
- Wirtz  Nikolaus
- Wolf  Gunter
- Wolf  Lothar
- Wong  Muh Geot
- Wong  Sze Ho Sunny
- Wong  Yick Hei
- Workeneh  Biruh
- Wu  Hon-Yen
- Wu  Ming-Ju
- Wyndham  Roger
- Yang  Jihyun
- Yang  Ju-Yeh
- Yeap  Chii
- Yim  Ka Fai
- Yong  Kenneth
- Yoo  Tae-Hyun
- Yoon  Songuk
- Yu  Tung-Min
- Yue  Tak Tai Andrew
- Zakari  Michel
- Zakauskiene  Urte
- Zaoui  Philippe
- Zbrzezniak  Justyna
- Zielinska  Dorota
- Zizzi  Carlotta Federica
- Publication venue
- Publication date
- 01/11/2023
- Field of study
BackgroundSparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.MethodsPROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.FindingsBetween Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.InterpretationOver 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function
Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial
- Author
- Aaron Fearday
- Abdallah Geara
- Adam Morris
- Adriana Fernandes
- Adriana Sierra Ochoa
- Aejin Kim
- Agata Winiarska
- Aine Maire De Bhailis
- Ajay Dhaygude
- Alastair Gillies
- Alba Atenza
- Alberto Ortiz Arduan
- Alejandro Soria Villen
- Alessia Fornoni
- Alex Mercer PhD g
- Alexandre Buffet
- Alexandre Karras
- Alfred Rodriguez
- Ali Assefi
- Allister Williams
- Allyson Medina
- Alvaro Vaz
- Alvita Vickiene
- Amanda Hall
- Amanda Mather
- Amanda Siriwardana
- Amar Mahdi
- Amy Henderson
- Amy Hudson
- An Vanacker
- Ana Avila Bernabeu
- Ana Carolina Figueiredo
- Ana Cortesão Costa
- Ana Farinha
- Ana Marta Gomes
- Ana Messias
- Ana Natario
- Ana Perez de Jose
- Ana Savuk
- Ana Vilar Gimeno
- Andrea Cavalli
- Andrea Solazzo
- Andrew Bomback
- Andrew Henderson
- Andrew McNally
- Angel Forcen
- Angel Sevillano
- Angus Ritchie
- Angus Turnbull
- Anna Benesova
- Anna Jander
- Anna Ricchiuto
- Anne Blanchard
- Anne-Elisabeth Heng
- Annegret Koch
- Annette Girardet
- Annie Reynolds
- Annika Adoberg
- Anoushka Krishnan
- Anthony Ting Pong Chan
- Antolina Moreno
- Antonio Galan Serrano
- Aparna Padiyar
- Archana Gautam
- Arksarapuk Jittirat
- Arnold Silva
- Aron Chakera
- Artashes Patrikyan
- Arun Gopu
- Arunima Jain
- Arvind Ponnusamy
- Asghar Chaudhry
- Asha Bailey
- Ashik Hayat
- Ashraf Mikhail
- Asta Auerbach
- Asta Stankuviene
- Aurore Labat
- Bamidele Ajayi
- Bang-Gee Hsu
- Barbara Greco
- Bart Maes
- Bassam Alchi
- Belen Vizcaino Castillo
- Bernd Hohenstein
- Bert Vandewiele
- Bertrand Dussol
- Bhadran Bose
- Bhavna Pandya
- Biruh Workeneh
- Bogna Kwella
- Bojan Jelakovic
- Brad Rovin
- Bradley Nelson
- Brendon Neuen
- Brian Snow
- Britt Newsome
- Brittany Sheridan
- Bruce Baker
- Bruce Cooper
- Bruce Julian
- Bruce Spinowitz
- Camille Lanaret
- Caridad Martinez Villanueva
- Carlos Arias
- Carlos Gonzalez
- Carlotta Federica Zizzi
- Carmelita Marcantoni
- Carmen Sivo
- Carol Pollock
- Carole Philipponnet
- Caroline Dudreuilh
- Cassandra Kimber
- Catalina MartÃn Cleary
- Catarina Abrantes
- Catarina Almeida
- Catarina Teixeira
- Caterina Vita
- Catherine Janko
- Catherine Masset
- Cathylee Sly
- Celine Foote
- Chaim Charytan
- Chee Kay Cheung
- Chen Peh
- Cheng-Hsu Chen
- Cheuk Chun Szeto
- Chi Kwan Darwin Lam
- Chi-Chih Hung
- Chia-Tien Hsu
- Chiara Cogno
- Chien-Liang Chen
- Chien-Wei Huang
- Chih-Hsien Wang
- Chih-Yang Hsu
- Chii Yeap
- Christian Broyet
- Christian Combe
- Christiane Kettner
- Christine Ayvazyan
- Christophe Mariat
- Christopher Goldsmith
- Christopher Keller
- Chukwuma Chukwu
- Ciro Esposito
- Claire Rigothier
- Clara Barrios
- Clara Garcia Carro
- Clara Pardinhas
- Clarisse Greze
- Clement Dumond
- Clementine Nicolo
- Colin Geddes
- Constantina Chrysochou
- Cristina Medrano Villarroya
- Cyril Garrouste
- Damien Thibaudin
- Dan Pugh
- Dana Kim
- Dana Rizk
- Daniela Lopes
- Dariush Arfaania
- Dariusz Aksamit
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- David Packham
- David Semple
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- Daw-Yang Hwang
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- Diliana Draganova
- Dimitrios Moutzouris
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- Donald Brandon
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- Maria Menezes
- Marija Stankovic
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- Marine Livrozet
- Mario Cozzolino
- Mario Gois
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- Mario Ruiz
- Marius Miglinas
- Mark Lagatta
- Mark Lambie
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- Marta Calvo Arevalo
- Martial Moonen
- Martin Busch
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- Martin Gallagher
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- Martina Milicevic
- MarÃa Vanessa Pérez Gómez
- Massimo Torreggiani
- Matias Trillini
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- Matthias Cassia
- May Tan
- Meera Patel Suthar
- Meg Jardine
- Mei-Chuan Kuo
- Mei-Fen Pai
- Melissa Cheetham
- Mercedes Gonzalez Moya
- Mercedes Salgueira Lazo
- Mercedes Velo Plaza
- Michael Collins
- Michael Germain
- Michel Zakari
- Michela Musolino
- Michelle N Rheault MD i
- Michelle O'Shaughnessy
- Ming-Ju Wu
- Ming-Shan Chang
- Mingyao Ma
- Mirco Belingheri
- Mirela Dobre
- Miriana Dinic
- Mohamad Kassem
- Mohammad Ali
- Mohammad Rony
- Mona Razavian
- Mona Wahba
- Monica Bordoli
- Monica Furlano
- Monica Limardo
- Montserrat Diaz Encarnacion
- Moon Hyoung Lee
- Muh Geot Wong
- Muh Geot Wong PhD m n
- Muralikrishna Gangadharan
- Myung-Gyu Kim
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- Natalia Allende Burgos
- Natalia Ramos Terrades
- Nathan Lorde
- Nayan Gowda
- Nazareno Carullo
- Neeraj Dhaun
- Neil Boudville
- Nicholas Gray
- Nick Mansfield
- Nicolas Maillard
- Nicole Douthit
- Nicolino Comi
- Nikhil Thyagarajan
- Nikolaus Wirtz
- Nisha Clement
- Nishigandha Pradhan
- Nishita Parikh
- Noemie Chiche-Jourde
- Norbert Kwella
- Norberto Perico
- Nuno Fonseca
- Olga Gracia Garcia
- Oliver Flossmann
- Olivia Wickens
- Olivier Schockaert
- Omar Sherin Ibrahim Ragy
- Paolo Randone
- Paramit Chowdhury
- Patricia Alves
- Patricia Valerio Santos
- Patrick Hamilton
- Patrick Mark
- Patrizia Passerini
- Paul Manley
- Pedro Okoh
- Peter Doubel
- Peter Hollett
- Peter Hollett
- Peter Sizeland
- Philip Clayton
- Philippe Zaoui
- Phillip Madonia
- Piergiorgio Messa
- Pierre-Louis Carron
- Pietro Canetta
- Pietro Napodano
- Piotr Jaskowski
- Po-Tsang Lee
- Po-Yu Tseng
- Pradip Chowdhury
- Praveena Jyothinagaram
- Priscilla Smith
- Prof Brad Rovin MD j
- Prof Charles E Alpers MD d
- Prof Hiddo J L Heerspink PhD a b
- Prof Howard Trachtman MD k
- Prof Irene L Noronha MD h
- Prof Jai Radhakrishnan MD c
- Prof Jonathan Barratt PhD e
- Prof Vlado Perkovic MD b ofor the PROTECT Investigators†Author links open overlay panelEric Alarmartine
- Przemyslaw Miarka
- Rachel Jones
- Radko Komers MD f
- Radu Jacob
- Raffi Minasian
- Rajan Patel
- Rajdeep Gadh
- Ramachandra Patak
- Ranjit Dhelaria
- Rathika Krishnasamy
- Rathika Krishnasamy
- Raul Fernandez Prado
- Richard Lafayette
- Rishi Pruthi
- Ritesh Raichoudhury
- Robert Carroll
- Robert Davidson
- Robert Haws
- Robert Malecki
- Roberta Aliotta
- Rocco Baccaro
- Roderick Comunale
- Roderick Comunale
- Roger Wyndham
- Rouzbeh Afsari
- Roxane Gaisset
- Rui Barata
- Sadia Jahan
- Saif Al Chalabi
- Salem Almaani
- Salia Virxinia Pol Heres
- Sam Daneshvari
- Samir Parikh
- Sandra Karanovic
- Sang-Kyung Jo
- Sapna Shah
- Sara Fernandes
- Sara Goncalves
- Sara Ombelet
- Sara Vigano
- Sarah Ashley Ford Sightler
- Sarah Lawman
- Sarah Quinn
- Sarah Roxburgh
- Saravanan Balamuthusamy
- Se Joong Kim
- Sebahat Sat
- Secundino Cigarran Guldris
- Selena Longhi
- Serena Ponti
- Seung Hyeok Han
- SeWon Oh
- Shamik Bhadra
- Shang-Feng Tsai
- Shang-Jyh Hwang
- Sharon Adler
- Shaundeep Sen
- Sheng Kuo
- Shih-Hsiang Ou
- Shih-Ping Hsu
- Shilpanjali Jesudason
- Sian Griffin
- Siddhartha Kattamanchi
- Silja Sanden
- Silvia Malvica
- Simon Mucha
- Simon Roger
- Simone Accarino
- Simone Kulka
- Siu Fai Cheung
- Smeeta Sinha
- Sofia Jorge
- Sofie Jamar
- Songuk Yoon
- Sradha Kotwal
- Sreedhar Mandayam
- Stacy Martinez
- Stefan Weiner
- Stefanie Stangenberg
- Stefano Costanzi
- Stephan Christian Werth
- Stephane Burtey
- Stephane Roueff
- Stephen McDonald
- Stewart Bieler BA a
- Sui Kon
- Suneel Udani
- Sunggyun Kim
- Susan Crail
- Susan Wan
- Suzanne Forbes
- Sven Heinrichs
- Sydney Chi Wai Tang
- Syeda Ahmad
- Sze Ho Sunny Wong
- Szu-Yu Pan
- Sónia Silva
- Tae-Hyun Yoo
- Tak Tai Andrew Yue
- Tamara Malek Marin
- Tania Salehi
- Teresa Furtado
- Theodoros Kasimatis
- Thida Maung Maung Myint
- Thilo Krueger
- Thomas Bucknall
- Thomas Malfait
- Thomas Powell
- Thomas Weinreich
- Thu Nguyen
- Tiane Dai
- Toby Coates
- Tomasz Stompor
- Tung-Min Yu
- Tze Goh
- Tzung-Yo Ho
- Ulrich Kunzendorf
- Ulysses Diva PhD f
- Unnikrishnan Pillai
- Unnikrishnan Pillai
- Ursula Verdalles Guzman
- Urte Zakauskiene
- Usha Peri
- Valentin Mayet
- Valérie de Précigout
- Veronica Viramontes
- Victor Fernandez
- Victoria Campbell
- Victoria Campbell
- Vidu Wijeratne
- Viet Nguyen
- Viet Nguyen
- Vittoria Esposito
- Vladmir Tesar
- Wai Lim
- Wai Ping Law
- Wan-Chuan Tsai
- Wanja Bernhardt
- Wenceslao Adrian Aguilera Morales
- William Paxton
- William Rote PhD f
- Wim Lemahieu
- Wladyslaw Sulowicz
- Wooin Ahn
- Wookyung Chung
- Xavier Warling
- Yahsou Delmas
- Yan Li
- Yelena Drexler
- Yen-Ling Chiu
- Yeong Hoon Kim
- Yi-Wen Chiu
- Yick Hei Wong
- Yonatan Peleg
- Young Rim Song
- YoungYoul Hyun
- Yu-Sen Peng
- Yunmi Kim
- Yusuf Eqbal
- Yusuf Eqbal
- Yvonne Shen
- Zivka Dika
- Zoltan Endre
- Zvonimir Sitas
- Publication venue
- Publication date
- 01/01/2023
- Field of study
Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics
Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial
- Author
- Aaron Fearday (17386231)
- Abdallah Geara (17386297)
- Adam Morris (2043517)
- Adriana Fernandes (8856416)
- Adriana Sierra Ochoa (17386699)
- Aejin Kim (2175798)
- Agata Winiarska (17387086)
- Aine Maire De Bhailis (17386168)
- Ajay Dhaygude (10682946)
- Alastair Gillies (17386309)
- Alba Atenza (17385991)
- Alberto Ortiz Arduan (17385973)
- Alejandro Soria Villen (17387041)
- Alessia Fornoni (519467)
- Alex Mercer (59669)
- Alexandre Buffet (14930766)
- Alexandre Karras (506611)
- Alfred Rodriguez (17386840)
- Ali Assefi (17385988)
- Allister Williams (17387083)
- Allyson Medina (17386612)
- Alvaro Vaz (17387023)
- Alvita Vickiene (6473255)
- Amanda Hall (210816)
- Amanda Mather (285324)
- Amanda Siriwardana (17386933)
- Amar Mahdi (10295868)
- Amy Henderson (17386369)
- Amy Hudson (8412594)
- An Vanacker (17387017)
- Ana Avila Bernabeu (17386036)
- Ana Carolina Figueiredo (17386246)
- Ana Cortesão Costa (5670833)
- Ana Farinha (17386228)
- Ana Marta Gomes (2851424)
- Ana Messias (17386621)
- Ana Natario (17386672)
- Ana Perez de Jose (17386768)
- Ana Savuk (17386891)
- Ana Vilar Gimeno (17386312)
- Andrea Cavalli (102196)
- Andrea Solazzo (4768362)
- Andrew Bomback (17386042)
- Andrew Henderson (2641108)
- Andrew McNally (1982641)
- Angel Forcen (17386264)
- Angel Sevillano (17386918)
- Angus Ritchie (9950267)
- Angus Turnbull (17387002)
- Anna Benesova (17386033)
- Anna Jander (17386405)
- Anna Ricchiuto (17386831)
- Anne Blanchard (480536)
- Anne-Elisabeth Heng (4164625)
- Annegret Koch (17386468)
- Annette Girardet (17386315)
- Annie Reynolds (8204301)
- Annika Adoberg (17385931)
- Anoushka Krishnan (12896624)
- Anthony Ting Pong Chan (17386099)
- Antolina Moreno (17386657)
- Antonio Galan Serrano (17386915)
- Aparna Padiyar (17386714)
- Archana Gautam (402849)
- Arksarapuk Jittirat (17386420)
- Arnold Silva (17386930)
- Aron Chakera (239959)
- Artashes Patrikyan (17386744)
- Arun Gopu (17386342)
- Arunima Jain (17386402)
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- Vlado Perkovic (141532)
- Wai Lim (3583598)
- Wai Ping Law (12288571)
- Wan-Chuan Tsai (5476856)
- Wanja Bernhardt (245782)
- Wenceslao Adrian Aguilera Morales (17386651)
- William E Rote (17385919)
- William Paxton (17386750)
- Wim Lemahieu (3547811)
- Wladyslaw Sulowicz (17386969)
- Wooin Ahn (17385943)
- Wookyung Chung (610342)
- Xavier Warling (17387056)
- Yahsou Delmas (4034183)
- Yan Li (23143)
- Yelena Drexler (12365018)
- Yen-Ling Chiu (442530)
- Yeong Hoon Kim (8962688)
- Yi-Wen Chiu (106535)
- Yick Hei Wong (12288568)
- Yonatan Peleg (9922071)
- Young Rim Song (13242926)
- Young Youl Hyun (13016397)
- Yu-Sen Peng (315725)
- Yunmi Kim (3040866)
- Yusuf Eqbal (17386222)
- Yvonne Shen (17386921)
- Zivka Dika (10281479)
- Zoltan Endre (714028)
- Zvonimir Sitas (17386936)
- Publication venue
- Publication date
- 01/12/2023
- Field of study
Background
Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.
Methods
PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.
Findings
Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.
Interpretation
Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function.</p
Low incidence of SARS-CoV-2, risk factors of mortality and the course of illness in the French national cohort of dialysis patients
- Author
- Abdallah Guerraoui
- Abdelatif Benmoussa
- Abdelaziz Hamani
- Abdelaziz Ziane
- Abdelhamid Abbassi
- Abdelhamid Nefti
- Abdelkader Hadj
- Abderrahim El Amari
- Abderrahmane Ghazali
- Abo Bakr Abd El Fatah Mohamed
- Achour Laradi
- Adel Ben Ahmed
- Adel Sahar
- Adele Pillet
- Adeline Lacraz
- Adnan Moinat
- Afshin Massoumi
- Agathe Pardon
- Agnes Caillette Beaudoin
- Agnes Chapelet Debout
- Agnes Mariot
- Ahmed Rachi
- Aida Afiani
- Aime Remy Boula
- Al Jalaby
- Alain Cremault
- Alain Debure
- Alain Fournier
- Alain Jeanson
- Alain Lyon
- Alain Nony
- Alain Robert
- Alain Slingeneyer
- Alanor Agnes Labatide
- Albane Brodin Sartorius
- Alberici
- Albert Bensman
- Albert Fournier
- Alex Ranlin
- Alex Vido Sandor
- Alexandra Colombo
- Alexandra Duhem
- Alexandra Stancu
- Alexandre Dufay
- Alexandre Dumoulin
- Alexandre Ebel
- Alexandre Klein
- Alexandre Martin
- Alexandre Mouneimne
- Alexandre Seidowsky
- Alfio De Martin
- Alfredo Zannier
- Ali Aizel
- Ali Hafi
- Ali Zineddine Diddaoui
- Alim Heyani
- Alina Mocanu
- Alina Preda
- Aline Hafi
- Aline Talaszka
- Alyette Duquesne
- Amar Amaouche
- Amel Ghemmour
- Amelie Simon
- Amina Skalli
- Amine Boukadida
- Amr Ekhlas Ragab Eid
- Ana Fedorca
- Anabelle Baillet
- Anais Poyet
- Ancuta Bouffandeau Giorgita
- Anderson Ratsimbazafy
- Andre Pruna
- Angel Argiles
- Angelo Testa
- Ann Karolien Vandooren
- Anne Elisabeth Heng
- Anne Gaelle Josse
- Anne Helene Querard
- Anne Helene Reboux
- Anne Jolivot
- Anne Kolko Labadens
- Anne Lataste
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- Paul Finielz
- Paul Stroumza
- Paule Hardy Yverneau
- Pauline Caillard
- Pedro Palacin
- Perrine Aubertin
- Philippe Attias
- Philippe Brunet
- Philippe Brunet
- Philippe Chauveau
- Philippe Coindre
- Philippe Coste
- Philippe Dubot
- Philippe Fournier
- Philippe Hiernaux
- Philippe Jousset
- Philippe Lan Yue Wah
- Philippe Lang
- Philippe Le Cacheux
- Philippe Martin Dupont
- Philippe Michel
- Philippe Mirgaine
- Philippe Moriniere
- Philippe Nicoud
- Philippe Rieu
- Philippe Rousseau
- Philippe Sporer
- Philippe Thorel
- Philippe Vanhille
- Philippe Vigeral
- Philippe Zaoui
- Phirtskhalaishvili
- Pierre Alexandre Michel
- Pierre Bataille
- Pierre Brignon
- Pierre Filipozzi
- Pierre Francois Westeel
- Pierre Housset
- Pierre Louis Carron
- Pierre Peyronnet
- Pierre Ramperez
- Pierre Vautrin
- Pierre Yves Durand
- Pierrot Parent
- Piotr Seniuta
- Rabah Fraoui
- Rachel Tetaz
- Rachid Amaria
- Rachid Bourouma
- Rachid Djeffal
- Rachida Nebbad
- Radia Allal
- Radu Dimulescu
- Rafaat Boustani
- Rafik Mesbah
- Raifat Makdassi
- Raji Diab
- Raluca Puslenghea
- Raoul Roura
- Rateb Khayat
- Raymond Azar
- Raymond Frayssinet
- Regine Monkam
- Rehouni Boulahrouz
- Remi Boudet
- Renato Demontis
- Renaud Gansey
- Rene Cuvelier
- Renee Schmitt
- Reschad Noordally
- Reynald Binaut
- Rezkallah Latif
- Richard Dufresne
- Richard Montagnac
- Richard Reade
- Robert Genin
- Robert Novo
- Rocsana Fickl
- Roger Dufresne
- Roger Magnol
- Roland Issautier
- Romain Mortelette
- Ronan Delaval
- Ronan Lohro
- Roseline M'barga
- Roula Galland
- S. Beau
- Sabria Hacini
- Said Dahmoune
- Saliha Lekhal
- Salima Ahriz Sakso
- Salima Saksi
- Salvatore Citarda
- Samir Boubenider
- Samuel Kassis
- Sandra Verhille
- Sandrine Genestier
- Sandrine Muller
- Saoussen Krid
- Sarah Richter
- Sebastien Delbes
- Sebastien Mailliez
- Sebastien Veillon
- Seddick Benarbia
- Severine Beaudreuil
- Shen
- Siddiqi
- Sidi Ali Benyaghla
- Simon Duquennoy
- Simona Baluta
- Simona Boncila
- Sonia Mzoughi
- Sonia Ribal
- Sophie Acamer
- Sophie Chauvet
- Sophie Girerd
- Sophie Ozenne
- Sophie Parahy
- Sophie Rubens Duval
- Sophie Taque
- Soraya Menouer
- Soumaya Chargui
- Stanislas Bataille
- Stephane Barbier
- Stephane Billion
- Stephane Jean Martin
- Stephane Roueff
- Stephane Torner
- Stephanie Coupel
- Su
- Sylvie Cloarec
- Sylvie Lavaud
- Sylvie Leou
- Sébastien Nony
- T. Chatelet
- Tang
- Tania Onesta
- Tassadit Benhabib
- Tayeb Bensalem
- Theodora Dimulescu
- Theophile Sawadogo
- Thibault Dolley Hitze
- Thierry Baranger
- Thierry Boudemaghe
- Thierry Hannedouche
- Thierry Krummel
- Thierry Lobbedez
- Thierry Lobbedez
- Thierry Milcent
- Thomas Dervaux
- Thomas Guincestre
- Thomas Kofman
- Thomas Raphael
- Thomas Sadreux
- Tim Ulinski
- Tiphaine Guyon Roger
- Tomas Serrato
- Tomek Kofman
- Tony Wong
- Toufik Boubia
- Ubald Assogba Gbindoun
- Usama Khuzaie
- Valeri
- Valerie Caudwell
- Valerie Chatelet
- Valerie Crougneau
- Valerie De Precigout
- Valerie Drouillat
- Valerie Galantine
- Valerie Granveau Hugot
- Valerie Leroy
- Vardavas
- Veronique Boubia
- Veronique Falque
- Veronique Fournier
- Veronique Queron
- Veronique Viviani
- Victor Gueuttin
- Victor Panescu
- Victorio Menoyo Calonge
- Viet Nguyen
- Vincent Allot
- Vincent Delattre
- Vincent Leduc
- Vincent Pradier
- Violaine Emal Aglae
- Viorica Badulescu
- Virginia Molina
- Virginie Besson
- Virginie Chaigne
- Waddah Jaber
- Wael Boudi
- Wael El Haggan
- Wen Qin Guillon
- Wided Tabbi Aneni
- William Hanf
- Williamson
- Wladimir Kohn
- Xavier Bellenfant
- Xavier Moreau Gaudry
- Yahsou Delmas
- Yannick Knefati
- Yannick Saingra
- Yannick Tirolien
- Youssef Mann
- Yvan Brunak
- Yves Dimitrov
- Yves Doussy
- Yves Tanter
- Zaara Soltani
- Zacharia Boukerroucha
- Zafer Takla
- Zaid Benabid
- Zana Ramanantsialonina
- Zara Dickson
- Zead Tubail
- Zoe Koochaki Pour
- Zohra Boukhalfa
- Zohra Jacquot
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