EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety (EpleCsAT)
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|ClinicalTrials.gov Identifier: NCT01834768|
Recruitment Status : Unknown
Verified April 2013 by CHU de Reims.
Recruitment status was: Recruiting
First Posted : April 18, 2013
Last Update Posted : April 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Insufficiency Kidney Transplantation||Drug: Eplerenone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||December 2013|
- Occurence of an adverse event requiring the discontinuation of eplerenone [ Time Frame: 8 weeks ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834768
|Contact: Philippe RIEUemail@example.com|
|Centre Hospitalier Universitaire de Reims||Recruiting|
|Reims, France, 51092|
|Contact: Philippe RIEU, PhD, MD firstname.lastname@example.org|
|Principal Investigator: Philippe RIEU, PhD, MD|