• David Wayne Johnson, Carmel Mary Hawley, Brenda Rosser, Elaine Beller, Charles Thompson, Robert G Fassett, Paolo Ferrari, Stephen MacDonald, Eugenie Pedagogos, and Alan Cass.
• Australian Kidney Trials Network, School of Population Health, University of Queensland, Brisbane, Australia. david_johnson@health.qld.gov.au
• Bmc Nephrol. 2008 Jan 1;9:8.

BackgroundThe main hypothesis of this study is that Oxpentifylline administration will effectively treat erythropoietin- or darbepoietin-resistant anaemia in chronic kidney disease patients.Methods/DesignInclusion criteria are adult patients with stage 4 or 5 chronic kidney disease (including dialysis patients) with significant anaemia (haemoglobin or= 200 IU/kg/week) or darbepoetin (>or= 1 microg/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.DiscussionThis 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.

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