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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01832558
Eligibility Criteria:
Inclusion Criteria:
* CKD II to III and diabetes mellitus type 2
* CKD will be defined according to estimated glomerular filtration rate (eGFR) with the MDRD formula
* eGFR between 30 and 89 ml/min
* albumin excretion rates \> 300 mg/24 hours (UACR \> 300 mg/gram) or \> 200 mg/g if already receiving any RAS blockade Patients should be hypertonic stage I or II according to the European guidelines (Chobanian et al. JAMA 2003)
Exclusion Criteria:
* Age \< 18 years
* UACR \> 3500mg/g
* severe hypertension
* pregnancy
* unwilling or inability to sign the informed consent
* coronary heart disease
* systolic blood pressure \< 130 mmHg
* additional RAS interfering drugs (ACEis, ARBs, direct renin inhibitors)
* 25-hydroxy vitamin D levels below 16.6±8.3 pg/ml
* 1,25-dihydroxy vitamin D 33.1±15.5 pg/ml
Intolerance to eplerenon or an excipient of it:
tablettcore: Lactose-Monohydrat Mikrokristalline Cellulose (E 460) Croscarmellose-sodium (E 468) Hypromellose (E 464) Sodiumdodecylsulfat Talkum (E 553b) Magnesiumstearat (E 470b)
filmcoat
Opadry, yellow:
Hypromellose (E 464) Titandioxid (E 171) Macrogol 400 Polysorbat 80 (E 433) Yellow ironoxide (E 172) Red ironoxide (E 172)
* Patients with Serumpotassium \> 5,0 mmol/l at start of the treatment
* Patients with severe renal insufficiency (eGFR \<30ml/min./1.73 m2)
* Patients with severe liver insufficiency (Child-Pugh class C)
* Patients taking potassium saving diuretics, potassium supplements or strong CYP3A4-inhibitors (z. B. Itraconazol, Ketoconazol, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin und Nefazodon)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01832558
Study Brief:
Protocol Section:
NCT01832558