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Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

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ClinicalTrials.gov Identifier: NCT00318812
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : May 2, 2014
Last Update Posted : May 10, 2016
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Renal Failure Drug: Heme Iron Polypeptide (Proferrin) Drug: Iron sucrose (Venofer) Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2007
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

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 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

Primary Outcome Measures :
  1. Hemoglobin Concentration at 6 Months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Ferritin [ Time Frame: 6 months ]
    Comparison of Ferritin at 6 months between the 2 Groups

  2. Transferrin Saturation [ Time Frame: 6 Months ]
    Comparison of Transferrin Saturation between the Groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318812

Canada, Ontario
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Deborah Zimmerman, MD Ottawa Hospital Research Institute

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
First Posted: April 27, 2006    Key Record Dates
Results First Posted: May 2, 2014
Last Update Posted: May 10, 2016
Last Verified: April 2016

Keywords provided by Ottawa Hospital Research Institute:
Randomized controlled trial (RCT)
Prospective Studies
ferric oxide, saccharated
Treatment Outcome

Additional relevant MeSH terms:
Renal Insufficiency
Anemia, Iron-Deficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs