Conditions: Kidney Transplantation Renal Transplantation
Keywords: Transplant Renal transplant Rejection,allograf Rejection Xenograft rejection Host vs graft disease Kidney Transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 612
Healthy volunteers: no

Brief summary:
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Everolimus intervention 2: Tacrolimus intervention 3: Cyclosporin A intervention 4: Enteric Coated Mycophenolate Sodium (EC-MPS) intervention 5: Mycophenolate mofetil (MMF) intervention 6: Corticosteroids intervention 7: Simulect
Intervention descriptions: intervention 1: None intervention 2: Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels intervention 3: Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml intervention 4: Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose intervention 5: Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose intervention 6: A minimum dose of 5 mg prednisolon or equivalent intervention 7: Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Protocol document: