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

Sponsored by:	Ottawa Hospital Research Institute
Information provided by:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00318812

Purpose

The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as 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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Heme Iron Polypeptide for the Treatment of Iron Deficiency Anaemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Sucrose Ferric oxide, saccharated

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 mmonths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Iron indicies IV iron requirements rHuEpo requirements Adverse events/side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	May 2007
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Heme Iron: Experimental Heme Iron Polypeptide 11mg PO tid for 6 months	Drug: Heme Iron Polypeptide (Proferrin) Heme iron polypeptide 11mg po tid for 6 months
Venofer: Active Comparator Venofer Qmonthly IV x 6 months	Drug: Iron sucrose (Venofer) Iron sucrose infusion IV Qmontly x 6 months

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:

Transferrin saturation > 50%
Ferritin > 800 mcg/L
Malignancy, recurrent GI bleeding, major surgery or infection within the last 3 months
Parentral iron therapy or blood transfusion within the last 3 months
Pregnancy
Contraindication or hypersensitivity to any study medication (heme iron polypeptide, iron sucrose or darbepoetin alpha)
Inability or refusal to give consent

Contacts and Locations

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

Locations

Canada, Ontario
The Ottawa Hospital - Riverside Campus	Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Deborah Zimmermam, MD 613-738-8400 ext 82534 dzimmerman@ottawahospital.on.ca
Contact: Jan Davis, MD 613-738-8400 ext 82892 jdavis@ottawahospital.on.ca
Sub-Investigator: Adam Cohn, MD
Principal Investigator: Deborah Zimmerman, MD
Sub-Investigator: Janet Lynn Davis, MD

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

Study Director:

Deborah Zimmerman, MD

Ottawa Hospital Research Institute

More Information

No publications provided

Responsible Party:	Kidney Research Centre ( Deborah Zimmerman )
Study ID Numbers:	2005840-01H
Study First Received:	April 25, 2006
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00318812 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:

RCT
Prospective Studies
ferric oxide, saccharated
Peptides
Heme
Iron

Erythropoietin,
Recombinant
Ferritin
Transferrin
Treatment Outcome

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Metabolic Diseases
Hematinics
Hematologic Diseases
Kidney Failure, Chronic
Anemia
Trace Elements
Iron Metabolism Disorders

Anemia, Iron-Deficiency
Ferric oxide, saccharated
Urologic Diseases
Renal Insufficiency, Chronic
Micronutrients
Kidney Diseases
Metabolic Disorder
Iron
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Hematinics
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Anemia
Kidney Failure, Chronic
Anemia, Hypochromic
Trace Elements

Iron Metabolism Disorders
Pharmacologic Actions
Anemia, Iron-Deficiency
Ferric oxide, saccharated
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Micronutrients
Kidney Diseases
Iron
Kidney Failure

ClinicalTrials.gov processed this record on August 30, 2009