Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00318812
First received: April 25, 2006
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


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 Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

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

Secondary Outcome Measures:
  • Ferritin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Comparison of Ferritin at 6 months between the 2 Groups

  • Transferrin Saturation [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Comparison of Transferrin Saturation between the Groups


Enrollment: 55
Study Start Date: May 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
The Ottawa Hospital Research Institute
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: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00318812     History of Changes
Other Study ID Numbers: 2005840-01H
Study First Received: April 25, 2006
Results First Received: June 26, 2013
Last Updated: April 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Randomized controlled trial (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
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
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 July 23, 2014