A Phase 2 interventional study of Eplerenone in Chronic Kidney Insufficiency and Kidney Transplantation, sponsored by CHU de Reims. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-18.
Sponsored by CHU de Reims · Phase 2, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 172 are open to participants now.
This study's planned enrollment of 31 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
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All the patients that will be included in this trial have to fulfil all the following conditions:
Exclusion Criteria:
All the patients that will be included in this trial have to fulfil no one of the following conditions:
Eplerenone
Drug: Eplerenone
Occurence of an adverse event requiring the discontinuation of eplerenone
Occurrence of an adverse event requiring the discontinuation of eplerenone: * serum potassium higher than or equal to 6mmol/L and/or higher than or equal to 5.5mmol/L under 2 measuring spoons of KAYEXALATE® * acidosis evidenced by serum alkaline reserve lower than or equal to 15mmol/L * systemic hypotension evidenced by a systolic blood pressure lower than 100mHg * orthostatic hypotension evidenced by a decrease of systolic blood pressure more than 20mmHg to the transition to upright posture within 3 minutes * acute kidney failure evidenced by an increase of serum creatinine more than 30% from the starting value (at the date of inclusion) * every other adverse event unscheduled by investigators, only if it requires the discontinuation of eplerenone
Time frame: 8 weeks
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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CHU de Reims