The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)

Launched by MEDICAL UNIVERSITY OF VIENNA · Apr 15, 2013

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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)