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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
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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 Design
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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
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


Locations
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Canada, Ontario
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Deborah Zimmerman, MD Ottawa Hospital Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00318812    
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
Peptides
Heme
Iron
 Erythropoietin,
Recombinant
Ferritin
Transferrin
Treatment Outcome
Additional relevant MeSH terms:
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Renal Insufficiency
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Kidney Diseases
 Urologic Diseases
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Physiological Effects of Drugs
Hematinics