Status:
COMPLETED
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Anemia
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 dis...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00318812
Start Date
May 1 2007
End Date
December 1 2011
Last Update
May 10 2016
Active Locations (1)
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1
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9