Conditions: Kidney Transplantation
Keywords: Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 313

Brief summary:
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.

Detailed description:

Arms:
arm 1: In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. arm 2: In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.

Interventions: intervention 1: Enteric-coated mycophenolate sodium (Myfortic) intervention 2: Cyclosporine (Neoral) intervention 3: Prednisone
Intervention descriptions: intervention 1: 1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. intervention 2: cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels intervention 3: 20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Protocol document: