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A Randomized, Placebo-Controlled Trial of Pentoxifylline on Erythropoiesis-Stimulating Agent Hyporesponsiveness in Anemic Patients With CKD: The Handling Erythropoietin Resistance With Oxpentifylline (HERO) Trial

Johnson, David W., Pascoe, Elaine M., Badve, Sunil V., Dalziel, Kim, Cass, Alan, Clarke, Philip, Ferrari, Paolo, McDonald, Stephen P., Morrish, Alicia T., Pedagogos, Eugenie, Perkovic, Vlado, Reidlinger, Donna, Scaria, Anish, Walker, Rowan, Vergara, Liza A. and Hawley, Carmel M. (2015). A Randomized, Placebo-Controlled Trial of Pentoxifylline on Erythropoiesis-Stimulating Agent Hyporesponsiveness in Anemic Patients With CKD: The Handling Erythropoietin Resistance With Oxpentifylline (HERO) Trial. American Journal of Kidney Diseases,65(1):49-57.

Document type: Journal Article
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IRMA ID 75039815xPUB253
Title A Randomized, Placebo-Controlled Trial of Pentoxifylline on Erythropoiesis-Stimulating Agent Hyporesponsiveness in Anemic Patients With CKD: The Handling Erythropoietin Resistance With Oxpentifylline (HERO) Trial
Author Johnson, David W.
Pascoe, Elaine M.
Badve, Sunil V.
Dalziel, Kim
Cass, Alan
Clarke, Philip
Ferrari, Paolo
McDonald, Stephen P.
Morrish, Alicia T.
Pedagogos, Eugenie
Perkovic, Vlado
Reidlinger, Donna
Scaria, Anish
Walker, Rowan
Vergara, Liza A.
Hawley, Carmel M.
Journal Name American Journal of Kidney Diseases
Publication Date 2015
Volume Number 65
Issue Number 1
ISSN 0272-6386   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-84922433423
Start Page 49
End Page 57
Total Pages 9
Place of Publication United States
Publisher W.B. Saunders Co.
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
Erythropoiesis-stimulating agent (ESA)-hyporesponsive anemia is common in chronic kidney disease (CKD). Pentoxifylline shows promise as a treatment for ESA-hyporesponsive anemia, but has not been rigorously evaluated.

Study Design
Multicenter, double-blind, randomized, controlled trial.

Setting & Participants
53 adult patients with CKD stage 4 or 5 (including dialysis) and ESA-hyporesponsive anemia (hemoglobin ≤ 120 g/L and ESA resistance index [calculated as weight-adjusted weekly ESA dose in IU/kg/wk divided by hemoglobin concentration in g/L] ≥ 1.0 IU/kg/wk/g/L for erythropoietin-treated patients and ≥0.005 μg/kg/wk/g/L for darbepoetin-treated patients).

Interventions
Pentoxifylline (400 mg/d; n = 26) or matching placebo (control; n = 27) for 4 months.

Outcomes
Primary outcome: ESA resistance index at 4 months; secondary outcomes: hemoglobin concentration, ESA dose, blood transfusion requirement, serum ferritin level and transferrin saturation, C-reactive protein level, adverse events, quality of life, and health economics.

Results
There was no statistically significant difference in ESA resistance index between the pentoxifylline and control groups (adjusted mean difference, −0.39 [95% CI, −0.89 to 0.10] IU/kg/wk/g/L; P = 0.1). Pentoxifylline significantly increased hemoglobin concentration relative to the control group (adjusted mean difference, 7.6 [95% CI, 1.7-13.5] g/L; P = 0.01). There was no difference in ESA dose between groups (−20.8 [95% CI, −67.2 to 25.7] IU/kg/wk; P = 0.4). No differences in blood transfusion requirements, adverse events, or quality of life were observed between groups. Pentoxifylline cost A$88.05 (US $82.94) per person over the trial and produced mean savings in ESA cost of A$1,332 (US $1,255). The overall economic impact over the trial period was a saving of A$1,244 (US $1,172) per person for the pentoxifylline group compared with controls.

Limitations
Sample size smaller than planned due to slow recruitment.

Conclusions
Pentoxifylline did not significantly modify ESA hyporesponsiveness, but increased hemoglobin concentration. Further studies are warranted to determine whether pentoxifylline therapy represents a safe strategy for increasing hemoglobin levels in patients with CKD with ESA-hyporesponsive anemia.
DOI http://dx.doi.org/10.1053/j.ajkd.2014.06.020   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
 
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