Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure - Full Text View

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 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:

MedlinePlus related topics: Anemia Iron

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 months ]

Secondary Outcome Measures:

Ferritin [ Time Frame: 6 months ]
Comparison of Ferritin at 6 months between the 2 Groups
Transferrin Saturation [ Time Frame: 6 Months ]
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 (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:

Iron overload (Tsat > 50% or ferritin > 800 μg/L);
malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
parenteral iron therapy, blood transfusion within the last 3 months;
pregnancy;
contraindication to any study medication and;
inability or refusal to give consent.

Contacts and Locations

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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

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
Study First Received:	April 25, 2006
Results First Received:	June 26, 2013
Last Updated:	April 5, 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

ClinicalTrials.gov processed this record on May 25, 2017