Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Conditions
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Renal Transplantation, Chronic Renal Allograft Failure

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Cyclosporine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral | Drug: Tacrolimus<br>* Oral<br>* Other names: Prograf;|
| Active Comparator: 2<br>Oral | Drug: Cyclosporine<br>* Oral<br>* Other names: Neoral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Cyclosporine, Tacrolimus, Intervention, Interstitial Fibrosis Tubular Atrophy, Chronic Renal Allograft Failure