Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome

Introduction: Alport syndrome is a rare genetic disorder that affects as many as 60,000 persons in the USA and a total of 103,000 persons (200 pg/mL at baseline or with significant cardiovascular histories were excluded. Patients were randomized 1:1 to bardoxolone methyl or placebo, with stratification by baseline UACR. Results: A total of 371 patients were screened, and 157 patients were randomly assigned to receive bardoxolone methyl (n = 77) or placebo (n = 80). The average age at screening was 39.2 years, and 23 (15%) were <18 years of age. Of the randomized population, 146 (93%) had confirmed genetic diagnosis of Alport syndrome, and 62% of patients had X-linked mode of inheritance. Mean baseline eGFR was 62.7 mL/min/1.73 m2, and the geometric mean UACR was 141.0 mg/g. The average annual rate of eGFR decline prior to enrollment in the study was -4.9 mL/min/1.73 m2 despite 78% of the patient population receiving ACE inhibitor (ACEi) or ARB therapy. Discussion/Conclusion: CARDINAL is one of the largest interventional, randomized controlled trials in Alport syndrome conducted to date. Despite the use of ACEi or ARB, patients were experiencing significant loss of kidney function prior to study entry

Measuring collective action intention toward gender equality across cultures

Collective action is a powerful tool for social change and is fundamental to women and girls’ empowerment on a societal level. Collective action towards gender equality could be understood as intentional and conscious civic behaviors focused on social transformation, questioning power relations, and promoting gender equality through collective efforts. Various instruments to measure collective action intentions have been developed, but to our knowledge none of the published measures were subject to invariance testing. We introduce the gender equality collective action intention (GECAI) scale and examine its psychometric isomorphism and measurement invariance, using data from 60 countries (N = 31,686). Our findings indicate that partial scalar measurement invariance of the GECAI scale permits conditional comparisons of latent mean GECAI scores across countries. Moreover, this metric psychometric isomorphism of the GECAI means we can interpret scores at the country-level (i.e., as a group attribute) conceptually similar to individual attributes. Therefore, our findings add to the growing body of literature on gender based collective action by introducing a methodologically sound tool to measure collective action intentions towards gender equality across cultures

Utilisation d'un test de cytosensibilité pour l'étude de l'ozonation de composés aromatiques substitués

Les auteurs décrivent l'utilisation d'un test de cytosensibilité utilisant des cellules BGM, modification plus sensible de ceux décrits auparavant par CHRISTIAN (1973) et ELIAS et Col. (1978). Les essais d'ozonation ont porté sur quatre composés aromatiques substitués (aniline, nitro-p-crésol, chloro-o-crésol et acide benzène sulfonique) dont l'évolution a été suivie à différents temps par la mesure de la disparition du composé initial, de la DBO5 et de la DCO, du carbone organique dissous et de la cytosensibilité. Après l'addition des solutions ozonées à la suspension cellulaire et incubation pendant 3 jours à 37°C, le contenu résiduel en protéine mesuré par la méthode de Lowry a permis de quantifier la cytotoxicité du mélange. Les solutions d'aniline, de nitro - et de chlorocrésol ont montré une évolution identique : augmentation de la cytotoxicité au début de l'ozonation qui atteint un maximum pour la dégradation de 50 à 90 % du composé initial, suivie d'une diminution et d'une disparition tandis que la biodégradabilité augmente. Les variations semblent être en relation avec la formation de produits intermédiaires d'oxydation toxiques. Ces résultats préliminaires suggèrent que ce type de test, à la fois simple et rapide, peut être très utile dans l'étude des effets biologiques de procédures d'oxydation sur des eaux très chargées