Conditions: Kidney Diseases
Keywords: Randomized Controlled Trials Immunosuppression Adult Kidney Transplantation Treatment Outcome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 334
Healthy volunteers: no

Brief summary:
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Detailed description:
Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection.

Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus

Arms:
arm 1: Low dose voclosporin arm 2: Mid Dose Voclosporin arm 3: High Dose Voclosporin arm 4: Standard Dose Tacrolimus

Interventions: intervention 1: Voclosporin intervention 2: tacrolimus
Intervention descriptions: intervention 1: voclosporin 0.4, 0.6, 0.8 mg/kg po BID intervention 2: tacrolimus 0.05 mg/kg po BID

Protocol document: