Conditions: Kidney Transplant
Keywords: Kidney transplant renal transplant immunosuppression mycophenolate mofetil tacrolimus everolimus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 613
Healthy volunteers: no

Brief summary:
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

Detailed description:

Arms:
arm 1: Everolimus (EVR) and tacrolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was \< 3 ng/mL, or reduced if the trough level was \> 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. arm 2: Mycophenolate mofetil and tacrolimus (MMF) treatment arm: MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. Tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, target level of tacrolimus was reduced to 5 - 8 ng/mL.

Interventions: intervention 1: Everolimus and tacrolimus intervention 2: mycophenolate mofetil and tacrolimus
Intervention descriptions: intervention 1: Everolimus:

* Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
* Dose: 1.5 mg per day
* Frequency: 0.75 mg twice daily

Tacrolimus:

* Dose adjusted to maintain specific blood levels intervention 2: Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Protocol document: