Status:
UNKNOWN
The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)
Lead Sponsor:
Medical University of Vienna
Conditions:
CKD II-III
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per day after a two week ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01832558
Start Date
November 1 2012
End Date
December 31 2021
Last Update
June 19 2020
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090