Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferrous Sulfate; Drug: Venofer

• Registration Number: NCT00236977
• Lead Sponsor: American Regent, Inc.

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.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-12
• Results First Submitted: 2009-01-14
• Results First Submitted QC: 2010-02-22
• Results First Posted: 2010-03-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Hemoglobin < or = 11.5 gm/dL
• Stable dose or not receiving EPO
• Renal Anemia

Exclusion Criteria

• IV iron with last 6 months
• Chronic infection, malignancy,major surgery within last month
• Blood Transfusion with last two months
• Significant blood loss within last 3 months
• Concomitant sever diseases of the liver

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous Sulfate	Ferrous Sulfate	oral iron
Venofer	Venofer	iron sucrose injection

Primary Outcome Measures

Name	Time	Method
Patients With an Increase in Hemoglobin >= 1gm/dL.	Change from Baseline up to Day 56

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With a Clinical Response	Change from Baseline up to Day 56	Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml)
Mean Change in Ferritin (ng/mL) From Baseline to Day 56	Change from Baseline at Day 56
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56	Change from Baseline up to Day 56
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56	Change from Baseline up to Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56	Change from Baseline at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56	Change from Baseline at Day 56

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Valley Forge, Pennsylvania, United States