Conditions: Kidney Transplantation
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.

Detailed description:

Arms:
arm 1: Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month. arm 2: Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month.

Interventions: intervention 1: MMF intervention 2: EC-MPS intervention 3: Prednisone
Intervention descriptions: intervention 1: 1 g per day b.i.d. p.o. for at least 1 month intervention 2: 720 mg b.i.d. p.o. for at least 1 month intervention 3: 5 mg per day p.o.

Protocol document: