NCT01102218

A Safety Study of Pentoxifylline for the Treatment of Anemia

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Erythropoietin	Standard of Care
DRUG	Erythropoietin	Standard of Care
DRUG	Pentoxifylline	400 mg qd po for 6 months

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-04-13
• Last updated: 2012-03-28
• Results posted: 2012-03-26

Locations

10 sites across 1 country: United States