Status:
TERMINATED
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
Eligibility Criteria
Inclusion
- Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
- Subject is 18 years of age or over at the time of transplant.
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Exclusion
- Recipients of a kidney from a donor 60 years of age or older
- Recipients of donation after cardiac death (DCD) donors
- Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
- Subjects with a second renal allograft who had their original graft for \< 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
- Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) \>20
- Subjects with hepatitis B \& C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
- Subjects receiving an allograft with cold ischemia time 24 hours or greater
- Subjects who have received an investigational drug within three months prior to randomization
- Subjects who are breastfeeding
- Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
- Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00133172
Start Date
July 1 2005
End Date
March 1 2007
Last Update
September 8 2014
Active Locations (14)
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1
Calgary, Alberta, Canada, T2N 2T9
2
Edmonton, Alberta, Canada, T6G 2B7
3
Vancouver, British Columbia, Canada, V5Z 1C6
4
Vancouver, British Columbia, Canada, V6Z 1Y6