Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: a randomized controlled trial.
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
Inclusion criteria are adult patients with stage 4 or 5 chronic kidney disease (including dialysis patients) with significant anaemia (haemoglobin <or= 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 (>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.


CONCLUSIONS
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.
Johnson
David Wayne
DW
Australian Kidney Trials Network, School of Population Health, University of Queensland, Brisbane, Australia. david_johnson@health.qld.gov.au
Hawley
Carmel Mary
CM
Rosser
Brenda
B
Beller
Elaine
E
Thompson
Charles
C
Fassett
Robert G
RG
Ferrari
Paolo
P
MacDonald
Stephen
S
Pedagogos
Eugenie
E
Cass
Alan
A
D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D001772:Blood Cell Count; D001803:Blood Transfusion / Q000706:statistics & numerical data; D000068256:Darbepoetin alfa; D004311:Double-Blind Method; D004351:Drug Resistance; D004920:Erythropoiesis / Q000187:drug effects; D004921:Erythropoietin / Q000031:analogs & derivatives / Q000494:pharmacology; D006397:Hematinics / Q000494:pharmacology / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications*; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D010431:Pentoxifylline / Q000494:pharmacology / Q000627:therapeutic use*; D012107:Research Design; D018401:Sample Size
D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D010431:Pentoxifylline