Kidney Transplantation Clinical Trial
Official title:
Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients
Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive
drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A)
are widely used. Their renal toxicity could be divided between an acute toxicity (toxic
arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy,
interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have
shown the implication of the mineralocorticoid receptor (MR) activation in those toxic
phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the
renal function and kidney histological damages.
Several antagonists are available in France but none is indicated in kidney transplantation.
Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and
to have less adverse anti-androgenic effects than others molecules. Its principal adverse
events are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists,
especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced
by calcineurin-inhibitors.
Classically, eplerenone is contra-indicated in patients presenting with an impaired renal
function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a
warning is especially notified for the association with cyclosporine A due to the fact that
no study have been done in this context.
The investigators study first the safety of the use of eplerenone in association with
cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will
study its efficiency in a large randomized controlled trial.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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