The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9, Canada
NCT Number: NCT00318812
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Ottawa, Ontario, K1H 7W9, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heme iron polypeptide 11mg po tid for 6 months
Other names: Proferrin
Iron sucrose infusion IV q month x 6 months
Other names: Venofer
Time frame: 6 months
Time frame: 6 months
Comparison of Ferritin at 6 months between the 2 Groups
Time frame: 6 Months
Comparison of Transferrin Saturation between the Groups
Ottawa Hospital Research Institute
Other
Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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