EpleCsATStudy of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients

Date de début de l'étude : 1 février 2013

Inclusion Criteria: All the patients that will be included in this trial have to fulfil all the following conditions: more than 18-years old at the date of inclusion a full legal capacity belonging to a health care system give their written consent a functional kidney allograft for at least 1 year from the date of inclusion be under cyclosporine A-treatment impaired renal function estimated by the MDRD formula between 30 to 50mL/min/1.73m² Exclusion Criteria: All the patients that will be included in this trial have to fulfil no one of the following conditions: serum potassium higher than or equal to 5mmol/L at the date of inclusion one or more history of severe hyperkalemia (serum potassium higher than or equal to 6mmol/L) whatever the reason currently under potassium exchange resin treatment like KAYEXALATE® an acute rejection of the graft within the 6 months before the date of inclusion an ongoing pregnancy or a lack of effective contraception during all the study an uncontrolled high arterial blood pressure an orthostatic hypotension a systolic arterial blood pressure under or equal to 110mmHg a heart failure within the past 3 months before the date of inclusion or a chronic heart failure (stages III or IV of the NYHA classification) a severe hepatic failure (stage C of the Child-Pugh classification) an allergy to one or more of the components of the speciality eplerenone - INSPRA® an ongoing treatment with spironolactone - ALDACTONE® or eplerenone - INSPRA® a contra-indicated association whose treatment could not be suspended during the study: potassium sparing diuretics, potassium salts, enzymatic inhibitors of CYP3A4 (like itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, telithromycine, nefazodone) a malabsorption syndrome, an abnormality of galactose metabolism or a deficiency in galactase an ongoing treatment with nonsteroidal anti-inflammatory or with lithium or another nephrotoxic agent an ongoing treatment with a double-blockade of the Renin-Angiotensin-Aldosterone System by the association ACE-I (Angiotensin-Converting Enzyme Inhibitor) and ARB (Angiotensin Receptor Blocker)