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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Iron Sucrose + Erythropoietin; Drug: Oral Iron + Erythropoietin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236964

1VEN99012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Iron Sucrose

Experimental group

Description:

Iron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29

Treatment:

Drug: Iron Sucrose + Erythropoietin

Oral Iron

Active Comparator group

Description:

Oral ferrous sulfate 325 mg three times a day on Days 1 to 29.

Treatment:

Drug: Oral Iron + Erythropoietin