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

David Wayne Johnson; Carmel Mary Hawley; Brenda Rosser; Elaine Beller; Charles Thompson; Robert G. Fassett; Paolo Ferrari; Stephen MacDonald; Eugenie Pedagogos; Alan Cass

doi:10.1186/1471-2369-9-8

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

David Wayne Johnson^*, Carmel Mary Hawley, Brenda Rosser, Elaine Beller, Charles Thompson, Robert G. Fassett, Paolo Ferrari, Stephen MacDonald, Eugenie Pedagogos, Alan Cass

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

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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 = 200 IU/kg/week) or darbepoetin (>= 1 mu g/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.

Original language	English
Article number	8
Number of pages	7
Journal	BMC Nephrology
Volume	9
DOIs	https://doi.org/10.1186/1471-2369-9-8
Publication status	Published - 2008
Externally published	Yes

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Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemiaFinal published version, 371 KBLicence: CC BY

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title = "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 = 200 IU/kg/week) or darbepoetin (>= 1 mu g/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.",

author = "Johnson, {David Wayne} and Hawley, {Carmel Mary} and Brenda Rosser and Elaine Beller and Charles Thompson and Fassett, {Robert G.} and Paolo Ferrari and Stephen MacDonald and Eugenie Pedagogos and Alan Cass",

year = "2008",

doi = "10.1186/1471-2369-9-8",

language = "English",

volume = "9",

journal = "BMC Nephrology",

issn = "1471-2369",

publisher = "BioMed Central Ltd.",

}

TY - JOUR

T1 - Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia

T2 - A randomized controlled trial

AU - Johnson, David Wayne

AU - Hawley, Carmel Mary

AU - Rosser, Brenda

AU - Beller, Elaine

AU - Thompson, Charles

AU - Fassett, Robert G.

AU - Ferrari, Paolo

AU - MacDonald, Stephen

AU - Pedagogos, Eugenie

AU - Cass, Alan

PY - 2008

Y1 - 2008

N2 - 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 = 200 IU/kg/week) or darbepoetin (>= 1 mu g/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.

AB - 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 = 200 IU/kg/week) or darbepoetin (>= 1 mu g/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.

U2 - 10.1186/1471-2369-9-8

DO - 10.1186/1471-2369-9-8

M3 - Article

SN - 1471-2369

VL - 9

JO - BMC Nephrology

JF - BMC Nephrology

M1 - 8

ER -

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

Abstract

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