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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01832558
First received: April 8, 2013
Last updated: April 15, 2013
Last verified: April 2013

April 8, 2013
April 15, 2013
November 2012
April 2013   (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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Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
CKD II-III
  • 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.
 
Recruiting
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April 2013   (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)

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)
Both
18 Years and older
No
Contact: Marcus Saemann, MD 0043/404005593 marcus.saemann@meduniwien.ac.at
Austria
 
NCT01832558
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
April 2013

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