Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Inclusion criteria

• Patient is the recipient of a cadaveric or living donor renal transplant.
• Patient was > 12 years of age at the time of transplant.
• Patient is at least 3 months post-transplant.
• Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
• Patient has one of the following risk factors for chronic renal allograft failure:

I. Serum creatinine > 2.0 mg/dL 3 months or later post-transplant in males patients.

II. Serum creatinine > 1.7 mg/dL 3 months or later post-transplant in female patients.

III. Serum > 30% increased over post discharge nadir.

• Patients had a renal biopsy that shows chronic allograft nephropathy.
• Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
• If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants.

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Exclusion criteria

• Patient is the recipient of a solid organ transplant other than the kidney.
• Patient is dialysis dependent.
• Patient has recurrence of primary renal disease, or de novo renal disease.
• Patient has an estimated creatinine clearance <25ml/min calculated using the Cockcroft/Gault formula.
• Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
• Baseline biopsy shows acute rejection Banff Grade > Class 2 (IIB).
• Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
• Patient has received an investigational immunosuppressant within three months.
• Patient is pregnant or lactating.
• Patient is a known carrier of any of the HIV viruses.
• Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.