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.
BMC Nephrology © 2008 Johnson et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Professor Johnson has received consultancy fees and speaker's honoraria from Sanofi-Aventis (manufacturer of oxpentifylline). He has also received consultancy fees, speaker's honoraria, research grants and conference travel sponsorships from Amgen, Janssen-Cilag and Roche (all manufacturers of erythropoiesis stimulating agents).
Dr. Hawley has received conference travel sponsorships from Amgen and Janssen- Cilag.
Professor Ferrari has received speaker's honoraria and conference travel sponsorships from Amgen, Roche and Janssen-Cilag.
Dr McDonald has received speaker's honoraria, and conference travel sponsorships from Amgen and Janssen-Cilag (manufacturers of erythropoiesis stimulating agents).
Associate Professor Alan Cass has received speaker's honoraria and research grants from Amgen, Janssen-Cilag and Roche.
The remaining authors declare that they have no financial competing interests.
Non-Financial Competing Interests
The authors declare that they have no non-financial competing interests.
Authors' Contributions
DJ: Principal Investigator; conceived study; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. CH: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. BR: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. EB: Trial Management Committee member; participated in design and co-ordination; provided statistical advice; helped to draft manuscript; read and approved the final manuscript. CT: Trial Management Committee member; participated in design and co-ordination; provided statistical advice; helped to draft manuscript; read and approved the final manuscript. RB: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. PF: Trial Management Committee member; conceived hepcidin sub-study; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. SM: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. EP: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript. AC: Trial Management Committee member; participated in design and co-ordination; helped to draft manuscript; read and approved the final manuscript.
Cite this: Oxpentifylline Versus Placebo in the Treatment of Erythropoietin-resistant Anaemia: A Randomized Controlled Trial - Medscape - Aug 01, 2008.
Comments