Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 disease.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

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:

1. Iron overload (Tsat > 50% or ferritin > 800 μg/L);

2. malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;

3. parenteral iron therapy, blood transfusion within the last 3 months;

4. pregnancy;

5. contraindication to any study medication and;

6. inability or refusal to give consent.