Overview

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