Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)
Status:
Unknown status
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
This prospective, interventional, open label, randomized, multicenter study was designed to
determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after
transplantation. Randomized patients are to be stable with their tacrolimus daily dose
required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility
assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of
the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual
dose. The benefit/risk ratio will include the assessment of renal function, histological
lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and
infectious diseases).