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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Hôpital Sud
Amiens, France
CHU de Angers
Angers, France
Hôpital Bois-Guillaume
Bois-Guillaume, France
Hôpital Cavale Blanche
Brest, France
CHU de Caen
Caen, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Dupuytren
Limoges, France
Hôpital Archet II
Nice, France
HEGP
Paris, France
...and 6 more locations
Renal function at one year post transplantation
Renal function at one year post transplantation estimated by the glomerular filtration rate (GFR) using MDRD 4 (Modification Diet in Renal Disease). Crude difference in renal function at one year between groups and the change of renal function between 4 months and one year in each group will be analyzed and compared.
Time frame: 12 months
To determine and compare according to randomized group
Routine graft histology at M12 assessed using Banff 2009 classification, with specific analysis of interstitial fibrosis (IF) using numeric quantification
Time frame: 12 months
To determine and compare according to randomized group
Glucose metabolism at M4 and M12
Time frame: 12 months
To determine and compare according to randomized group
Infection rate including BKV and CMV at M4 and M12
Time frame: 12 months
To determine and compare according to randomized group
Presence and intensity of Donor Specific Antibody (DSA) at M3 and M12
Time frame: 12 months
To determine and compare according to randomized group
Incidence of biopsy proven acute rejection episode at M12
Time frame: 12 months
To determine and compare according to randomized group
Graft and patient survival at M12
Time frame: 12 months
To determine and compare according to randomized group
Overall safety assessment
Time frame: 12 months
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