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

NCT ID: NCT00236977

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-10-31

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venofer

iron sucrose injection

Group Type: EXPERIMENTAL

Venofer

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Ferrous Sulfate

Intervention Type: DRUG

oral iron tablets; 325 mg three times a day orally for 56 days

Interventions

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.

Intervention Type: DRUG

Ferrous Sulfate

oral iron tablets; 325 mg three times a day orally for 56 days

Intervention Type: DRUG

Other Intervention Names

iron sucrose tablets; Oral Iron Tablets

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Luitpold Pharmaceuticals

Principal Investigators

Mark A Falone, MD

Role: STUDY_DIRECTOR

American Regent, Inc.

Locations

Luitpold Pharmaceuticals

Valley Forge, Pennsylvania, United States

Countries

United States

References

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. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.

Reference Type: RESULT

PMID: 16316362 (View on PubMed)

Other Identifiers

1VEN03027

Identifier Type: -

Identifier Source: org_study_id