Conditions: Renal Transplantation
Keywords: RenalTransplantation KidneyTransplantation MPA EC-MPS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: no

Brief summary:
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Detailed description:

Arms:
arm 1: Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. arm 2: Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.

Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Mycophenolate mofetil intervention 3: Placebo to mycophenolate sodium intervention 4: Placebo to mycophenolate mofetil
Intervention descriptions: intervention 1: Enteric-coated mycophenolate sodium supplied as 180 mg tablets. intervention 2: Mycophenolate mofetil supplied as 250 mg capsules. intervention 3: Placebo to mycophenolate sodium matching tablets. intervention 4: Placebo to mycophenolate mofetil matching capsules.

Protocol document: