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

Last updated: June 17, 2020
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01832558
EudraCT: 2012-002175-34
  • Ages 18-99
  • All Genders

Study 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 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CKD II to III and diabetes mellitus type 2

  • CKD will be defined according to estimated glomerular filtration rate (eGFR) with theMDRD formula

  • eGFR between 30 and 89 ml/min

  • albumin excretion rates > 300 mg/24 hours (UACR > 300 mg/gram) or > 200 mg/g ifalready receiving any RAS blockade Patients should be hypertonic stage I or IIaccording to the European guidelines (Chobanian et al. JAMA 2003)

Exclusion

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

  1. 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) Yellowironoxide (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 strongCYP3A4-inhibitors (z. B. Itraconazol, Ketoconazol, Ritonavir, Nelfinavir,Clarithromycin, Telithromycin und Nefazodon)

Study Design

Total Participants: 24
Study Start date:
November 01, 2012
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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