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

NCT ID: NCT01832558

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2021-12-31

Brief 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).

Conditions

CKD II-III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eplerenone

Eplerenone 25-50mg daily additionally to standard ACE-inhibition with enalapril 20mg daily

Group Type: EXPERIMENTAL

Eplerenone

Intervention Type: DRUG

Placebo

Placebo additionally to standard ACE-inhibition with enalapril 20mg daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Eplerenone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Marcus Saemann

Assoc. Prof. Priv.-Doz. Dr.med.univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Marcus Saemann, MD

Role: CONTACT

marcus.saemann@meduniwien.ac.at

0043/4040055930

Facility Contacts

Marcus Saemann, MD

Role: primary

marcus.saemann@meduniwien.ac.at

01/40400/55930

References

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):955-968. doi: 10.1038/ki.2011.505. Epub 2012 Feb 15.

Reference Type: BACKGROUND

PMID: 22336987 (View on PubMed)

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. doi: 10.2215/CJN.00240106. Epub 2006 Jul 19.

Reference Type: BACKGROUND

PMID: 17699311 (View on PubMed)

Other Identifiers

EudraCT: 2012-002175-34

Identifier Type: -

Identifier Source: org_study_id