Conditions: Renal Transplantation
Keywords: Renal Transplantation Immunosuppression Renal transplant recipients Gastrointestinal symptoms associated with MMF therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

Detailed description:

Arms:
arm 1: Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B. arm 2: Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.

Interventions: intervention 1: Enteric-coated Mycophenolate Acid (EC-MPA) intervention 2: Mycophenolate Mofetil (MMF) intervention 3: Placebo MMF intervention 4: Placebo EC-MPA
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: