The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and will be followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).
Patients randomized to the "withdrawal"group will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) will be obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.
Nantes University Hospital
Nantes, France
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).
Time frame: one year after complete withdrawal of Tacrolimus
Renal function
Improvement of renal function by measuring serum creatinine, using the original MDRD equation,
Time frame: one year after complete withdrawal
Acute rejection
Rate of histologically proven acute rejection by biopsy according to Banff classification 2009,
Time frame: one year after complete withdrawal
Chronic rejection
Rate of chronic rejection histologically proven by biopsy according to Banff classification 2009,
Time frame: One year after complete withdrawal
Steroid-resistant rejection
Rates of steroid-resistant rejection
Time frame: One year after complete withdrawal
Graft survival
Rate of return to dialysis (graft survival)
Time frame: One year after complete withdrawal
Cancer and infections
Incidence of cancer and infections
Time frame: one year after complete withdrawal
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Patients survival
Survival rate of patients
Time frame: One year after complete withdrawal
Anti-HLA antibodies
Appearance of anti-HLA donor specific and non-donor specific antibodies measured by the technique Luminex
Time frame: One year after complete withdrawal
Histological lesions of rejection
The appearance of histological lesions of cellular or humoral acute or chronic or subclinical rejection on the biopsy protocol
Time frame: One year after complete withdrawal
Histological lesions of fibrosis
Onset or worsening of histological lesions of interstitial fibrosis and tubular atrophy on biopsy inflammatory
Time frame: One year after complete withdrawal
Hypertension, hyperglycemia and hyperlipidemia
Incidence of hypertension, hyperglycemia and hyperlipidemia
Time frame: One year after complete withdrawal
Quality of life
Determination of the benefits of withdrawal of Tacrolimus on the quality of life of patients, defined by the scale of quality of life validated SF-36 used at the beginning (J-15) and at the end of the weaning period (J120) at 6 months (J300) and one year after complete withdrawal of Tacrolimus (J480)
Time frame: One year after complete withdrawal