Kidney transplantation is the standard treatment for patients with end-stage renal failure.
However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.
Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage.
Renal transplant patients treated with anticalcineurins for more than a year.
Stable renal function (defined by a creatinine level in µmol/l stable for 3 months (variation +/-20%)
Date of kidney transplant greater than 1 year
Age between 18 and 75 years inclusive
Stage 5 chronic renal failure (defined by a CKD-EPI GFR<15 ml/min/1.73m²)
Dialysis patient
History of myocardial infarction or stroke less than 6 months old
Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF <30%
Parallel
Belatacept
DrugChanging of anticalcineurins by Belatacept
anticalcineurins
DrugKeeping of anticalcineurins
Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries
The primary endpoint is to compare the variation over 6 months in the amplitude of endothelium-dependent dilation during the post-ischemic hyperemia maneuver (Paragraph 7.1) (visit V2 and V3) measured by vascular ultrasound with a automated software analysis in real time between the Bélatacept group and the anticalcineurin group.
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