Status:
TERMINATED
REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Kidney Failure, Chronic
Drug Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance. A multi-centered, open-label, randomized, controlled trial.
Detailed Description
Study Rationale Many treatable causes of erythropoietin resistance (also known as erythropoietin hypo-responsiveness) exist in patients with chronic kidney disease (CKD) stages 3 to 5 . Well recogniz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00319150
Start Date
October 1 2006
End Date
February 1 2009
Last Update
February 12 2009
Active Locations (7)
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1
Foothills Hospital
Calgary, Alberta, Canada
2
St. Paul's Hospital
Vancouver, British Columbia, Canada
3
Memorial University Medical Centre
St. John's, Newfoundland and Labrador, Canada
4
Kingston General Hospital
Kingston, Ontario, Canada