Conditions: Anemia
Keywords: CKD iron anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 182
Healthy volunteers: no

Brief summary:
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Detailed description:
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Arms:
arm 1: iron sucrose injection arm 2: oral iron

Interventions: intervention 1: Venofer intervention 2: Ferrous Sulfate
Intervention descriptions: intervention 1: iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. intervention 2: oral iron tablets; 325 mg three times a day orally for 56 days

Protocol document: