Status:
UNKNOWN
EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety
Lead Sponsor:
CHU de Reims
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Chronic Kidney Insufficiency
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01834768
Start Date
February 1 2013
End Date
December 1 2013
Last Update
April 18 2013
Active Locations (1)
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1
Centre Hospitalier Universitaire de Reims
Reims, France, 51092