Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.

Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00318812 History of Changes
Other Study ID Numbers:	2005840-01H
First Posted:	April 27, 2006
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:

Anemia; Renal Insufficiency; Anemia, Iron-Deficiency; Hematologic Diseases; Kidney Diseases; Urologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases	Iron; Ferric oxide, saccharated; Ferric Compounds; Trace Elements; Micronutrients; Growth Substances; Physiological Effects of Drugs; Hematinics