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Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
This study has been completed.
Sponsor:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00318812
First received: April 25, 2006
Last updated: April 5, 2016
Last verified: April 2016
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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:
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
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):
| 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 July 21, 2017