NCT00236964

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

Detailed description

Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Iron Sucrose + Erythropoietin	The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
DRUG	Oral Iron + Erythropoietin	Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Timeline

• Start date: 2001-02-23
• Primary completion: 2002-05-30
• Completion: 2002-05-30
• First posted: 2005-10-12
• Last updated: 2025-05-09