Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01834768
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01834768
Study Brief:
Protocol Section:
NCT01834768