Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

April 5, 2016 updated by: Ottawa Hospital Research Institute

Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.

Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • 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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital Research Institute

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:

  • eGFR < 30 mL/min
  • Hb 90-110 g/L
  • Age > 18
  • Not on renal replacement therapy
  • Transferrin saturation < 20% OR Ferritin <100 mcg/L
  • B12 & folate within reference range

Exclusion Criteria:

  1. Iron overload (Tsat > 50% or ferritin > 800 μg/L);
  2. malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
  3. parenteral iron therapy, blood transfusion within the last 3 months;
  4. pregnancy;
  5. contraindication to any study medication and;
  6. inability or refusal to give consent.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heme Iron
Heme Iron Polypeptide 11mg PO tid for 6 months
Drug: Heme Iron Polypeptide (Proferrin)
Heme iron polypeptide 11mg po tid for 6 months
Other Names:
  • Proferrin
Active Comparator: Venofer
Venofer q month IV x 6 months
Drug: Iron sucrose (Venofer)
Iron sucrose infusion IV q month x 6 months
Other Names:
  • Venofer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin Concentration at 6 Months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ferritin
Time Frame: 6 months
Comparison of Ferritin at 6 months between the 2 Groups
6 months
Transferrin Saturation
Time Frame: 6 Months
Comparison of Transferrin Saturation between the Groups
6 Months

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Deborah Zimmerman, MD, Ottawa Hospital Research Institute

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

May 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005840-01H

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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