Background: The main hypothesis of this study is that Oxpentifylline administration will effectively treat erythropoietin-or darbepoietin-resistant anaemia in chronic kidney disease patients

A Cooper

AC Cooper

Alan Cass

Brenda Rosser

Carmel Mary Hawley

CH Park

Charles Thompson

David Wayne Johnson

E Hernandez

E Nemeth

Elaine Beller

Eugenie Pedagogos

F Belloc

F Madore

F Valderrabano

H Kulaksiz

IC Macdougall

J Bienvenu

J Marton

J Semmler

J Stuart

JE Frampton

JF Navarro

JP Freitas

M Girndt

N Benbernou

P Lee

P Neuner

Paolo Ferrari

PJ Barnes

R Pecoits-Filho

RL Benz

Robert G Fassett

Stephen MacDonald

YE Taes

English

PubMed

Johnson, David Wayne

Hawley, Carmel Mary

Rosser, Brenda

Beller, Elaine

Thompson, Charles

Fassett, Robert G.

Ferrari, Paolo

MacDonald, Stephen

Pedagogos, Eugenie

Cass, Alan

University of Queensland eSpace

Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: A randomized controlled trial

Abstract Background The main hypothesis of this study is that Oxpentifylline administration will effectively treat erythropoietin- or darbepoietin-resistant anaemia in chronic kidney disease patients. Methods/design Inclusion criteria are adult patients with stage 4 or 5 chronic kidney disease (including dialysis patients) with significant anaemia (haemoglobin ≤ 110 g/L) for at least 3 months for which there is no clear identifiable cause and that is unresponsive to large doses of either erythropoietin (≥ 200 IU/kg/week) or darbepoetin (≥ 1 μg/kg/week). Patients will be randomized 1:1 to receive either placebo (1 tablet daily) or oxpentifylline (400 mg daily) per os for a period of 4 months. During this 4 month study period, haemoglobin measurements will be performed monthly. The primary outcome measure will be the difference in haemoglobin level between the 2 groups at the end of the 4 month study period, adjusted for baseline values. Secondary outcome measures will include erythropoiesis stimulating agent dosage, Key's index (erythropoiesis stimulating agent dosage divided by haemoglobin concentration), and blood transfusion requirement. Discussion This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their chronic kidney disease patients determine whether oxpentifylline represents a safe and effective strategy for treating erythropoiesis stimulating agent resistance in chronic kidney disease. Trial Registration Australian New Zealand Clinical Trials Registry Number ACTRN12608000199314.</p

Fassett Robert G

Thompson Charles

Beller Elaine

Rosser Brenda

Hawley Carmel

Johnson David

Ferrari Paolo

MacDonald Stephen

Pedagogos Eugenie

Cass Alan

Directory of Open Access Journals

BMC Nephrology

Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: a randomized controlled trial

Springer - Publisher Connector

Background. The main hypothesis of this study is that Oxpentifylline administration will effectively treat erythropoietin- or darbepoietin-resistant anaemia in chronic kidney disease patients. Methods/design. Inclusion criteria are adult patients with stage 4 or 5 chronic kidney disease (including dialysis patients) with significant anaemia (haemoglobin ≤ 110 g/L) for at least 3 months for which there is no clear identifiable cause and that is unresponsive to large doses of either erythropoietin (≥ 200 IU/kg/week) or darbepoetin (≥ 1 μg/kg/week). Patients will be randomized 1:1 to receive either placebo (1 tablet daily) or oxpentifylline (400 mg daily) per os for a period of 4 months. During this 4 month study period, haemoglobin measurements will be performed monthly. The primary outcome measure will be the difference in haemoglobin level between the 2 groups at the end of the 4 month study period, adjusted for baseline values. Secondary outcome measures will include erythropoiesis stimulating agent dosage, Key's index (erythropoiesis stimulating agent dosage divided by haemoglobin concentration), and blood transfusion requirement. Discussion. This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their chronic kidney disease patients determine whether oxpentifylline represents a safe and effective strategy for treating erythropoiesis stimulating agent resistance in chronic kidney disease. Trial Registration. Australian New Zealand Clinical Trials Registry Number ACTRN12608000199314. © 2008 Johnson et al; licensee BioMed Central Ltd

Johnson, DW

Hawley, CM

Rosser, B

Beller, E

Thompson, C

Fassett, RG

Ferrari, P

MacDonald, S

Pedagogos, E

Cass, A

UNSWorks

Crossref

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Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: a randomized controlled trial

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University of Queensland eSpace

Directory of Open Access Journals

Springer - Publisher Connector

UNSWorks

Springer - Publisher Connector

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