The intent of the study is initially to determine which RAD dose(s) are equivalent to MMF w/respect to the primary efficacy variables. Additionally, the study will assess the superiority of RAD over MMF for whichever dose(s) satisfy the equivalence criteria.
SPECIFIC AIMS : * To compare the efficacy of each of two oral doses of RAD. 1.5mg/d and 3.0mg/d with 2 gm/d mycophenolate mofetil as measured by the incidence of biopsy proven acute allograft rejection, graft loss, or death in the first six months of treatment in denovo renal transplant recipients. 1. To compare allograft and patient survival at 6, 12, 24, and 36 months post transplantation in de novo renal transplant recipients treated w/either RAD or mycophenolate mofetil. 2.To compare the efficacy of each of two oral doses (0.75mg bid and 1.5mg bid) of RAD w/1gm bid of mycophenolate mofetil as measured by the incidence of acute rejection in de novo renal transplant recipients at 6, 12, 24, and 36 months post transplantation. 3. To evaluate the safety of each of two oral doses of RAD compared to mycophenolate mofetil in de novo renal transplant recipients at 6, 12, 24, and 36 months post transplantation. 4. To compare the efficacy of each of two oral doses of RAD w/mycophenolate mofetil in the prevention of chronic allograft rejection in de novo renal transplant patients at 12, 24, and 36 months post transplantation. 5. To select the preferred dose of RAD based on safety and efficacy. 6. To assess the population pharmacokinetics of RAD during steady-state administration of Neoral in a subset of de novo renal transplant patients at selected centers. 7. To compare the health related quality of life (HRQoL) in de novo renal transplant patients treated w/ RAD or mycophenolate mofetil at Baseline and at Months 3, 6, 12, 24, and 36. 8. To collect medical care resource utilization data in de novo renal transplant patients treated w/RAD or mycophenolate mofetil.
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