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

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CKD II-III

Intervention: Eplerenone (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Medical University of Vienna

Overall contact:
Marcus Saemann, MD, Phone: 0043/404005593, Email: marcus.saemann@meduniwien.ac.at

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).

Clinical Details

Study design: Primary Purpose: Treatment

Primary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Marcus Saemann, MD, Phone: 0043/404005593, Email: marcus.saemann@meduniwien.ac.at

Medical University of Vienna, Vienna 1090, Austria; Recruiting
Marcus Saemann, MD, Phone: 01/40400/5593, Email: marcus.saemann@meduniwien.ac.at
Johannes Kovarik, MD, Sub-Investigator
Additional Information

Related publications:

Shavit L, Lifschitz MD, Epstein M. Aldosterone blockade and the mineralocorticoid receptor in the management of chronic kidney disease: current concepts and emerging treatment paradigms. Kidney Int. 2012 May;81(10):955-68. doi: 10.1038/ki.2011.505. Epub 2012 Feb 15. Review.

Epstein M, Williams GH, Weinberger M, Lewin A, Krause S, Mukherjee R, Patni R, Beckerman B. Selective aldosterone blockade with eplerenone reduces albuminuria in patients with type 2 diabetes. Clin J Am Soc Nephrol. 2006 Sep;1(5):940-51. Epub 2006 Jul 19.

Starting date: November 2012
Last updated: April 15, 2013

Page last updated: August 23, 2015

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