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

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ClinicalTrials.gov Identifier: NCT01832558
Recruitment Status : Recruiting
First Posted : April 16, 2013
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):

April 8, 2013
April 16, 2013
March 16, 2016
November 2012
December 2016   (Final data collection date for primary outcome measure)
Angiotensin levels (pg/ml) of CKD II-III patients with DM II with eplerenone additional to enalapril in comparison to patients who receive a placebo on top of enalapril therapy. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01832558 on ClinicalTrials.gov Archive Site
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The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)
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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 run-in phase. Thereafter, patients will either receive eplerenone 25mg (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method, quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang 2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of blood sera (after run-in phase and after 10 weeks).
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Phase 1
Phase 2
Primary Purpose: Treatment
  • Drug: Eplerenone
  • Drug: Placebo
  • Experimental: Eplerenone
    Eplerenone 25-50mg daily additionally to standard ACE-inhibition with enalapril 20mg daily
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Placebo
    Placebo additionally to standard ACE-inhibition with enalapril 20mg daily
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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December 2016
December 2016   (Final data collection date for primary outcome measure)

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)


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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Marcus Saemann, MD 0043/404005593 marcus.saemann@meduniwien.ac.at
EudraCT: 2012-002175-34
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Marcus Saemann, Medical University of Vienna
Medical University of Vienna
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Medical University of Vienna
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP