REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial
This study has been terminated.
(New evidence and trouble recruiting)
Sponsor:
Queen's University
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00319150
First received: April 26, 2006
Last updated: February 11, 2009
Last verified: February 2009
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Purpose
A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance. A multi-centered, open-label, randomized, controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure, Chronic Drug Resistance |
Drug: erythropoietin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Resistance to ErythroPoietin Effectiveness Algorithm Trial |
Resource links provided by NLM:
Further study details as provided by Queen's University:
Primary Outcome Measures:
- Primary End-points: [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
- Eprex® dose at the completion of the study period [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]
- Hemoglobin at completion of the study period (average of last 2 Hb measurements) [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of transfusions of packed red cells [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
- # of active infections during the study period (active infection is defined in Appendix B) [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
- Hospitalization [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
- Difference in HRQOL scores using Renal SF-36 scores taken at study start and completion study completion [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]
- Death [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | October 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard of Care
Epo dose to remain constant throughout study
|
|
|
Active Comparator: Dosage Decrease Arm
Arm 2 is to have an decrease of erythropoietin at regular intervals.
|
Drug: erythropoietin
Decrease dosage by 12.5% q 2 weeks according to an algorithm.
Other Name: Epo
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319150
Locations
| Canada, Alberta | |
| Foothills Hospital | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada | |
| Canada, Newfoundland and Labrador | |
| Memorial University Medical Centre | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada | |
| London Helath Sciences Centre | |
| London, Ontario, Canada | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada | |
| Humber River Regional Hosptial | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Queen's University
Ortho Biotech, Inc.
Investigators
| Principal Investigator: | Karen E Yeates, MD, FRCP(C), MPH | Queens University |
More Information
No publications provided
| Responsible Party: | Dr. Karen E. Yeates, Queens University |
| ClinicalTrials.gov Identifier: | NCT00319150 History of Changes |
| Other Study ID Numbers: | DMED-852-05 |
| Study First Received: | April 26, 2006 |
| Last Updated: | February 11, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Queen's University:
|
Erythropoetin resistance End Stage Renal Disease on hemodialysis |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013