Prospective, Multicenter, Randomized, Double-blind, Controlled Parallel Group Study Designed to Assess the Risk-benefit Balance of the Gradual Withdrawal of a Calcineurin Inhibitor (Tacrolimus) in Renal Transplant Patients Over 4 Years and Clinically Selected
Pre-inclusion criteria :
- Male or female aged between 18 and 80 years (inclusive),
- Having received a deceased donor transplant or living with ABO compatibility,
- First renal allograft for at least 4 years and under 10 years,
- Presenting a stable renal function : serum creatinine with a variation of ± 25% of
the average of the year before inclusion,
- Treated with tacrolimus (Prograf®) in combination with MPA (Cellcept® and Myfortic®)
+ / - steroids (between 5 and 10 mg per day),
- Patient has given informed consent,
- Patient insured,
- Patient (of childbearing age) with effective contraception.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Renal function
The primary endpoint will be the improvement of renal function one year after complete withdrawal of Tacrolimus (Prograf®) assessed by measuring the glomerular filtration rate (GFR) calculated by the dosage of cystatin C according to the equation Bricon. The DFG will be compared between times J-30 and J480 (1 year after the withdrawal).
one year after complete withdrawal of Tacrolimus
Yes
Magali GIRAL, Profesor
Principal Investigator
CHU de Nantes
France : AFSSAPS
09/7-D
NCT01292525
February 2011
October 2015
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