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

September 16, 2020 updated by: American Regent, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Valley Forge, Pennsylvania, United States, 19403
        • Luitpold Pharmaceuticals

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

Genders Eligible for Study

All

Description

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

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: Venofer
iron sucrose injection
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.
Other Names:
  • iron sucrose tablets
Active Comparator: Ferrous Sulfate
oral iron
Drug: Ferrous Sulfate
oral iron tablets; 325 mg three times a day orally for 56 days
Other Names:
  • Oral Iron Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients With an Increase in Hemoglobin >= 1gm/dL.
Time Frame: Change from Baseline up to Day 56
Change from Baseline up to Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With a Clinical Response
Time Frame: Change from Baseline up to Day 56
Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)
Change from Baseline up to Day 56
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Time Frame: Change from Baseline up to Day 56
Change from Baseline up to Day 56
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Time Frame: Change from Baseline up to Day 56
Change from Baseline up to Day 56
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Time Frame: Change from Baseline at Day 56
Change from Baseline at Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Time Frame: Change from Baseline at Day 56
Change from Baseline at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Time Frame: Change from Baseline at Day 56
Change from Baseline at Day 56

Collaborators and Investigators

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

Sponsor

American Regent, Inc.

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

August 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VEN03027

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.

Clinical Trials on Anemia

Clinical Trials on Venofer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe