Chronic Renal Allograft Failure, Renal Transplantation
Conditions
Keywords
Renal transplant, Cyclosporine, Tacrolimus, Intervention, Interstitial Fibrosis Tubular Atrophy, Chronic Renal Allograft Failure
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 immunosuppression to patients who remain on cyclosporine.
Interventions
DRUGTacrolimus
Oral
DRUGCyclosporine
Oral
Sponsors
Astellas Pharma Canada, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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 known carrier of any of the HIV viruses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft Survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Patient Survival | 5 years |
Countries
Canada
Outcome results
None listed