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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-23

Study Completion Date

2002-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron Sucrose

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

Group Type EXPERIMENTAL

Iron Sucrose + Erythropoietin

Intervention Type DRUG

The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Oral Iron

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

Group Type ACTIVE_COMPARATOR

Oral Iron + Erythropoietin

Intervention Type DRUG

Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Interventions

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Iron Sucrose + Erythropoietin

The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Intervention Type DRUG

Oral Iron + Erythropoietin

Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Intervention Type DRUG

Other Intervention Names

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Venofer Ferrous sulfate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No