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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Iron Sucrose + Erythropoietin; Drug: Oral Iron + Erythropoietin

• Registration Number: NCT00236964
• Lead Sponsor: American Regent, Inc.

Brief 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.

Study Timeline

• Study Start: 2001-02-23
• Primary Completion: 2002-05-30
• Study Completion: 2002-05-30
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2018-01
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Creatine Clearance <40 mL/min
• Average Baseline Hemoglobin < 10.5g/dL
• Serum Transferrin Saturation (TSAT) < 25% and Ferritin <300ng/mL

Exclusion Criteria

• Blood Transfusion within 30days
• Uncontrolled Hypertension
• Suffering form concommitant disease of the liver
• Serious bacterial infection
• Pregnancy / lactation
• Symptomatic HIV
• Expected to under dialysis or renal transplant during study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Sucrose	Iron Sucrose + Erythropoietin	Iron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29
Oral Iron	Oral Iron + Erythropoietin	Oral ferrous sulfate 325 mg three times a day on Days 1 to 29.

Primary Outcome Measures

Name	Time	Method
Mean Change in Hemoglobin	Baseline and Day 43	Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Mean Change in Serum Ferritin	Baseline and Day 43	Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).

Secondary Outcome Measures

Name	Time	Method
Clinical Success (Change in Hemoglobin)	Baseline and Day 43	Participants were considered to have achieved clinical success if they attained a change in hemoglobin ≥0.8 g/dL. The difference from baseline to Day 43 was calculated and rounded.
Clinical success (change in Ferritin)	Baseline and Day 43	Participants were considered to have achieved clinical success if they attained a change in ferritin ≥160 ng/mL. The difference from baseline to Day 43 was calculated and rounded.