Conditions: Kidney Transplantation
Keywords: Immunosuppression Kidney transplantation everolimus safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 383
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.

Detailed description:

Arms:
arm 1: Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months. arm 2: The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.

Interventions: intervention 1: Everolimus intervention 2: Mycophenolate sodium intervention 3: Cyclosporine intervention 4: Steroids
Intervention descriptions: intervention 1: Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally. intervention 2: Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating. intervention 3: Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally. intervention 4: Steroids were administered according to local clinical practice.

Protocol document: