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

May 6, 2025 updated by: American Regent, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron Sucrose
Iron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29
Drug: 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.
Other Names:
  • Venofer
Active Comparator: Oral Iron
Oral ferrous sulfate 325 mg three times a day on Days 1 to 29.
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.
Other Names:
  • Ferrous sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Hemoglobin
Time Frame: Baseline and Day 43
Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Baseline and Day 43
Mean Change in Serum Ferritin
Time Frame: Baseline and Day 43
Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Baseline and Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success (Change in Hemoglobin)
Time Frame: Baseline and Day 43
Participants were considered to have achieved clinical success if they attained a change in hemoglobin ≥0.8 g/dL. The difference from baseline to Day 43 was calculated and rounded.
Baseline and Day 43
Clinical success (change in Ferritin)
Time Frame: Baseline and Day 43
Participants were considered to have achieved clinical success if they attained a change in ferritin ≥160 ng/mL. The difference from baseline to Day 43 was calculated and rounded.
Baseline and Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Investigators

  • Study Director: Mark Falone, MD, Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2001

Primary Completion (Actual)

May 30, 2002

Study Completion (Actual)

May 30, 2002

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimated)

October 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VEN99012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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