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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236977
• Other study ID #: 1VEN03027
• Status: Completed
• Phase: Phase 3
• Start date: August 2003
• Est. completion date: October 2004

Study information

• Verified date: September 2020
• Source: American Regent, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Venofer
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.
• Ferrous Sulfate
oral iron tablets; 325 mg three times a day orally for 56 days

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	Valley Forge	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
American Regent, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With an Increase in Hemoglobin >= 1gm/dL.		Change from Baseline up to Day 56
Secondary	Number of Subjects With a Clinical Response	Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)	Change from Baseline up to Day 56
Secondary	Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56		Change from Baseline up to Day 56
Secondary	Highest Change From Baseline in Ferritin (ng/mL) up to Day 56		Change from Baseline up to Day 56
Secondary	Mean Change in Ferritin (ng/mL) From Baseline to Day 56		Change from Baseline at Day 56
Secondary	Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56		Change from Baseline at Day 56
Secondary	Mean Change From Baseline in Hemoglobin (g/dL) at Day 56		Change from Baseline at Day 56