Conditions: Kidney Transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief summary:
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms:
arm 1: Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.

Interventions: intervention 1: mycophenolate mofetil intervention 2: antibody induction intervention 3: Cyclosporine intervention 4: corticosteroid
Intervention descriptions: intervention 1: 1 g PO BID for 24 weeks intervention 2: According to manufacturer recommendation intervention 3: According to manufacturer recommendation intervention 4: According to manufacturer recommendation

Protocol document: