A Safety Study of Pentoxifylline for the Treatment of Anemia

Status:	Archived
Conditions:	Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:	Hematology, Nephrology / Urology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	August 2010
End Date:	December 2012

A Randomized Multi-Center Study to Determine the Safety and Efficacy of Erythropoietin Plus Pentoxifylline Versus Erythropoietin Alone for the Treatment of Anemia in Subjects With End Stage Renal Disease on Maintenance Hemodialysis

Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative
stress, which in turn contribute to anemia and cardiovascular disease.

Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown
promise in improving the treatment of patients with anemia. This study will examine the use
of pentoxifylline for the treatment of anemia in chronic kidney disease.

Treatment of the anemia of renal failure has been revolutionized by the use of
erythropoietin and other ESAs (erythropoiesis-stimulating agent). Concerns with ESA use
include a substantial number of End Stage Renal Disease (ESRD) patients with ESA-resistant
anemia, and a growing body of evidence of potential negative effects of high doses of ESA
use, including increased mortality and increased rate of tumor growth in cancer patients.

There are only a couple of small studies in the literature examining the effects of
pentoxifylline on anemia in patients with renal failure. The results are limited by the very
small number of patients. There is clearly a need for a larger, prospective, clinical trial
of pentoxifylline in ESRD patients, not limited to those with ESA-resistant anemia. This
would be the first prospective, randomized clinical trial of this size to study
pentoxifylline for the treatment of anemia in chronic kidney disease.

We found this trial at

sites

Fresenius Medical Care North America

Columbia, Tennessee 38478

from

Columbia, TN