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
  Purpose

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).


Condition Intervention Phase
CKD II-III
Drug: Eplerenone
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Study Start Date: November 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone
Eplerenone 25-50mg daily additionally to standard ACE-inhibition with enalapril 20mg daily
Drug: Eplerenone
Placebo Comparator: Placebo
Placebo additionally to standard ACE-inhibition with enalapril 20mg daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832558

Contacts
Contact: Marcus Saemann, MD 0043/404005593 marcus.saemann@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Marcus Saemann, MD    01/40400/5593    marcus.saemann@meduniwien.ac.at   
Sub-Investigator: Johannes Kovarik, MD         
Sponsors and Collaborators
Medical University of Vienna
  More Information

Publications:
Responsible Party: Marcus Saemann, Assoc. Prof. Priv.-Doz. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01832558     History of Changes
Other Study ID Numbers: EudraCT: 2012-002175-34
Study First Received: April 8, 2013
Last Updated: April 15, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014