Heart transplantation (TC) is the standard treatment for terminal heart failure. Chronic kidney disease (CKD) is a common complication responsible for increased mortality and morbidity. The main risk factors for progression to CKD are advanced age, pre-transplantation CKD, degradation of glomerular filtration rate (GFR) in the first year post-transplantation, and nephrotoxicity of calcineurin inhibitors (CNI). Indeed, these molecules (cyclosporin and tacrolimus), the cornerstone of immunosuppressive treatment, have nephrotoxic effects in the short term (by a hemodynamic effect) and in the long term (by a pro-fibrosin effect). In renal transplantation (TR), belatacept, a costimulation-inhibiting molecule, used de novo, without CNI, with induction by anti-receptor antibody of Interleukines 2, preserves kidney function. Despite this great advantage, its development is still hampered by a higher number of rejections compared to the CNI group in this originator study. Based on the experience gained in TR, which has since validated its use, the hypothesis is that in heart transplantation, belatacept (Nulojix) combined with minimization of CNI (with induction by antilymphocyte serum), could significantly improve glomerular filtration rate (GFR) in patients at risk of CKD (by removing them from dialysis and possible kidney transplantation) without increasing the risk of rejection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
9 injections of belatacept at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months 11 months and 12 months post graft
Karine Nubret
Bordeaux, France
RECRUITINGLaurent Sebbag
Lyon, France
RECRUITINGClaire Garandeau
Nantes, France
RECRUITINGBertrand Lelong
Rennes, France
RECRUITINGClearance
Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI (Chronic Kidney Disease - Epidemiology Collaboration) at 3 months and 12 months post heart transplantation
Time frame: 12 months
Myocardial biopsies
Myocardial biopsies between 3 months and 12 months post Cardiac Transplantation to check the risk of rejection
Time frame: 12 months
Anti-human leukocyte antigen antibody assay
To check the risk of rejection
Time frame: 12 months
Fasting blood glucose and glycated haemoglobin (HBA1C)
Measurement of the New Onset Diabetes After Transplantation
Time frame: 12 months
Death
Evaluate the mortality specific to 12 months post cardiac transplantation (Estimate: percentage of patients who died at 12 months).
Time frame: 12 months
Number of dialysis sessions
Evaluate the use of renal replacement therapy between 3 months and 12 months after Cardiac Transplantation.
Time frame: 12 months
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