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Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Ottawa Hospital Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00318812
First received: April 25, 2006
Last updated: November 16, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Anemia
Renal Failure
 Drug: Heme Iron Polypeptide (Proferrin)
Drug: Iron sucrose (Venofer)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Heme Iron Polypeptide for the Treatment of Iron Deficiency Anaemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Hemoglobin concentration at 6 months [ Time Frame: 6 mmonths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Iron indices IV iron requirements rHuEpo requirements Adverse events/side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: May 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Venofer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318812

Locations
Canada, Ontario
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Deborah Zimmerman, MD Ottawa Hospital Research Institute
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deborah Zimmerman, Kidney Research Centre
ClinicalTrials.gov Identifier: NCT00318812     History of Changes
Other Study ID Numbers: 2005840-01H
Study First Received: April 25, 2006
Last Updated: November 16, 2010
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
RCT
Prospective Studies
ferric oxide, saccharated
Peptides
Heme
Iron
 Erythropoietin,
Recombinant
Ferritin
Transferrin
Treatment Outcome

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Anemia, Iron-Deficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
 Ferric oxide, saccharated
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013