REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance. A multi-centered, open-label, randomized, controlled trial.

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

Details

• Lead Sponsor: Queen's University
• Collaborator: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• written informed consent

• Adult patients > 18 years old with current Epoetin Alpha dose >250 units/kg/wk

• Hemoglobin >90g/L or <130g/L

• Patients whom a temporary fall in Hb of up to 10g/L is deemed safe

• Patients not expected to have a change in the type of Epo or route of Epo therapy for the duration of the Study period

Exclusion Criteria:

• Known iron deficiency (% saturation <20 or ferritin <100)

• Vit B12 or folate deficiency (levels below normal limit for centre lab)

• Known malignancy (solid organ, leukemia or multiple myeloma)

• Jehovah's witness patients/those who refuse transfusion

• Expected to die in the next 6 months

• On dialysis less than 3 months

• Temporary (not tunneled) dialysis access catheter

• Pure red cell aplasia

• High likelihood of early withdrawal or interruption of the study (eg. severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)

• Planned major elective surgery during the study period

• Pregnancy or breast-feeding

• Women of child-bearing potential without effective contraception (abstinence, oral contraceptives, diaphragm, IUD)

• Administration of another investigational drug within 4 weeks before screening or planned during study period