Status:
COMPLETED
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Renal Transplantation
Chronic Renal Allograft Failure
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.
Detailed Description
The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunos...
Eligibility Criteria
Inclusion
- Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
- Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
- Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
- Serum creatinine: Male: \>=2.0mg/dL (176.8 umol/L); Female: \>= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
- Serum creatinine \> 30% increased over post-discharge nadir
- Patient has had a renal biopsy \> 3 months after transplant and within 6 months prior to enrollment
- Patient or legal guardian has signed and dated an IRB approved informed consent document
- Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)
Exclusion
- Patient is dialysis dependent and has recurrence of primary or de novo renal disease
- Patient has an estimated creatinine clearance \<25mL/min
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
- Baseline biopsy shows acute rejection Grade \>=IIB using Banff 95 criteria or \>= Grade IIA using Banff 97 criteria
- Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
- Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
- Patient is a known carrier of any of the HIV viruses
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00637143
Start Date
April 1 1999
End Date
February 1 2006
Last Update
February 16 2017
Active Locations (13)
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1
Calgary, Alberta, Canada, T2N 2T9
2
Edmonton, Alberta, Canada, T6G 2B7
3
Vancouver, British Columbia, Canada, V5Z 1M9
4
Winnipeg, Manitoba, Canada, R3A 1R9