Conditions: Anemia Renal Failure
Keywords: Randomized controlled trial (RCT) Prospective Studies ferric oxide, saccharated Peptides Heme Iron Erythropoietin, Recombinant Ferritin Transferrin Treatment Outcome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Heme Iron Polypeptide 11mg PO tid for 6 months arm 2: Venofer q month IV x 6 months

Interventions: intervention 1: Heme Iron Polypeptide (Proferrin) intervention 2: Iron sucrose (Venofer)
Intervention descriptions: intervention 1: Heme iron polypeptide 11mg po tid for 6 months intervention 2: Iron sucrose infusion IV q month x 6 months

Protocol document: