NCT01832558

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

8.2 years

First QC Date

April 8, 2013

Last Update Submit

June 17, 2020

Conditions

CKD II-III

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (2)

Eplerenone

EXPERIMENTAL

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

Drug: Eplerenone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EplerenoneDRUG
Eplerenone
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • hydroxy vitamin D levels below 16.6±8.3 pg/ml
  • ,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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22336987BACKGROUND

  • 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.

    PMID: 17699311BACKGROUND

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Marcus Saemann, MD

CONTACT

0043/4040055930marcus.saemann@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz. Dr.med.univ.

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 16, 2013

Study Start

November 1, 2012

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

AU(1)