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

Research output: Contribution to journalArticleResearchpeer-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 languageEnglish
Article number8
Number of pages7
JournalBMC Nephrology
Volume9
DOIs
Publication statusPublished - 2008
Externally publishedYes

Cite this

Johnson, David Wayne ; Hawley, Carmel Mary ; Rosser, Brenda ; Beller, Elaine ; Thompson, Charles ; Fassett, Robert G. ; Ferrari, Paolo ; MacDonald, Stephen ; Pedagogos, Eugenie ; Cass, Alan. / Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia : A randomized controlled trial. In: BMC Nephrology. 2008 ; Vol. 9.
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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",
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Johnson, DW, Hawley, CM, Rosser, B, Beller, E, Thompson, C, Fassett, RG, Ferrari, P, MacDonald, S, Pedagogos, E & Cass, A 2008, 'Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia: A randomized controlled trial' BMC Nephrology, vol. 9, 8. https://doi.org/10.1186/1471-2369-9-8

Oxpentifylline versus placebo in the treatment of erythropoietin-resistant anaemia : A randomized controlled trial. / Johnson, David Wayne; Hawley, Carmel Mary; Rosser, Brenda; Beller, Elaine; Thompson, Charles; Fassett, Robert G.; Ferrari, Paolo; MacDonald, Stephen; Pedagogos, Eugenie; Cass, Alan.

In: BMC Nephrology, Vol. 9, 8, 2008.

Research output: Contribution to journalArticleResearchpeer-review

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

VL - 9

JO - BMC Nephrology

JF - BMC Nephrology

SN - 1471-2369

M1 - 8

ER -