Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patient… (NCT00637143) | Clinical Trial Compass
CompletedPhase 4
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
Canada107 participantsStarted 1999-04
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …