Conditions: Renal Failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Detailed description:
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Arms:
arm 1: LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) arm 2: Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)

Interventions: intervention 1: LCP-Tacro tablets intervention 2: Prograf
Intervention descriptions: intervention 1: Tacrolimus intervention 2: Tacrolimus

Protocol document: