Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

April 29, 2021 updated by: American Regent, Inc.
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Study Type

Interventional

Enrollment (Actual)

121

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemoglobin >= 9.5 and <= 11.5 g/dL.
  • Ferritin <= 500 ng/ml.
  • Serum Transferrin Saturation (TSAT) <= 25%.
  • Stable erythropoietin (EPO) Regimen for 8 weeks.
  • No iron for last 4 weeks before randomization.

Exclusion Criteria:

  • Known Sensitivity to Iron Sucrose.
  • Suffering concomitant severe diseases of the liver & cardiovascular system.
  • Pregnancy / Lactation.
  • Inadequate dialysis.
  • Current treatment for asthma.
  • Significant blood loss.
  • Probability of need for transfusion or transfusion within 1 week of enrollment.
  • Anticipated major surgery.
  • Hemochromatosis / hemosiderosis.

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: Group A
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
Drug: Venofer and stable erythropoietin (EPO) regimen
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
Other Names:
  • Iron Sucrose
Active Comparator: Group B
Stable erythropoietin (EPO) dose and no supplemental iron.
Drug: stable erythropoietin (EPO) regimen
Stable erythropoietin (EPO) dose and no supplemental iron.
Other Names:
  • EPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change From Baseline to the Highest Hemoglobin up to Day 71
Time Frame: Change from Baseline up to Day 71
Change from Baseline up to Day 71

Secondary Outcome Measures

Outcome Measure
Time Frame
The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
Time Frame: Change from Baseline up to Day 71
Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Ferritin up to Day 71
Time Frame: Change from Baseline up to Day 71
Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
Time Frame: Change from Baseline up to Day 71
Change from Baseline up to Day 71

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

July 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 10, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VEN02021 / 1VEN02022

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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