Conditions: Renal Transplantation
Keywords: enteric-coated mycophenolate sodium, everolimus, CNI-free regimen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.

Detailed description:

Arms:
arm 1: Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids. arm 2: Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).

Interventions: intervention 1: Everolimus intervention 2: Cyclosporin A (CsA) intervention 3: Tacrolimus intervention 4: Enteric Coated - Mycophenolate Sodium (EC-MPS) intervention 5: Corticosteroids
Intervention descriptions: intervention 1: Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). intervention 2: The dose was based on the participants' blood level of C0h (80-150 ng/ml). intervention 3: The dose was based on the participants' blood level of C0h (5-10 ng/ml). intervention 4: The dose was ≥ 720 mg/day. intervention 5: Corticosteroids were given according to local standard and/or the Investigators' discretion.

Protocol document: