NCT00318812

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.

Detailed description

Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects. Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Conditions

• Anemia
• Renal Failure

Interventions

Type	Name	Description
DRUG	Heme Iron Polypeptide (Proferrin)	Heme iron polypeptide 11mg po tid for 6 months
DRUG	Iron sucrose (Venofer)	Iron sucrose infusion IV q month x 6 months

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2006-04-27
• Last updated: 2016-05-10
• Results posted: 2014-05-02

Locations

1 site across 1 country: Canada