Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients with Hypertension (EPOCH)

Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients with Hypertension (EPOCH) - EPOCH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002175-34-AT

Enrollment

Registered

2012-09-14

Start date

2012-10-23

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

proteinuric patients suffering from chronic kidney disease (II - III) ,diabetes mellitus II and hypertension

Interventions

Trade Name: Inspra Pharmaceutical Form: Film-coated tablet INN or Proposed INN: EPLERENONE CAS Number: 107724-20-9 Other descriptive name: EPLERENONE Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic kidney disease stages II-III (defined by MDRD formula) Diabetes mellitus type 2 (defined by WHO criteria) Urinary albumin to creatinine ratio (UACR) >300mg/g, UACR >200mg/g if already receiving RAS blockade Hypertension Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: Age 3500mg/g severe hypertension pregnancy unwilling or unability to sign the informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the quantitative differences between peptide profiles of CKD II-IV patients with diabetes mellitus type II with the aldosterone antagonist eplerenone additional to angiotensin converting enzyme inhibition versus patients who receive a placebo on top of ACEi therapy.;Secondary Objective: To determine if patients who receive single RAS blockade with ACEi, or combination with eplerenone exhibit rebound upregulation of potentially beneficial components (Ang 1-9, Ang 1-7) of the RAS system compared to the downregulation of Ang1-8. To demonstrate potential additional blood pressure lowering effects in patients receiving eplerenone additional to ACEi versus standard therapy with ACEi alone. To demonstrate potential additional antiproteinuric effects in patients receiving eplerenone additional to ACEi versus ACEi alone. ;Primary end point(s): Quantitative RAS peptide changes determined by mass spectrometry after a 2 month treatment with eplerenone additional to ACEi and ACEi alone;Timepoint(s) of evaluation of this end point: after run-in phase and after 2 months of treatment	—

Measure

Time frame

Main Objective: To demonstrate the quantitative differences between peptide profiles of CKD II-IV patients with diabetes mellitus type II with the aldosterone antagonist eplerenone additional to angiotensin converting enzyme inhibition versus patients who receive a placebo on top of ACEi therapy.;Secondary Objective: To determine if patients who receive single RAS blockade with ACEi, or combination with eplerenone exhibit rebound upregulation of potentially beneficial components (Ang 1-9, Ang 1-7) of the RAS system compared to the downregulation of Ang1-8. To demonstrate potential additional blood pressure lowering effects in patients receiving eplerenone additional to ACEi versus standard therapy with ACEi alone. To demonstrate potential additional antiproteinuric effects in patients receiving eplerenone additional to ACEi versus ACEi alone. ;Primary end point(s): Quantitative RAS peptide changes determined by mass spectrometry after a 2 month treatment with eplerenone additional to ACEi and ACEi alone;Timepoint(s) of evaluation of this end point: after run-in phase and after 2 months of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Extent of RAS upregulation of potentially beneficial components (Ang 1-9, Ang 1-7) of the RAS after RI phase with ACEi monotherapy and in comparison after treatment phase with eplerenone Blood pressure reduction, determined by ambulatory blood pressure measurements Proteinuria reduction, measured by UACR after each study phase;Timepoint(s) of evaluation of this end point: after run-in phase and after 2 months of treatment	—

Measure

Time frame

Secondary end point(s): Extent of RAS upregulation of potentially beneficial components (Ang 1-9, Ang 1-7) of the RAS after RI phase with ACEi monotherapy and in comparison after treatment phase with eplerenone Blood pressure reduction, determined by ambulatory blood pressure measurements Proteinuria reduction, measured by UACR after each study phase;Timepoint(s) of evaluation of this end point: after run-in phase and after 2 months of treatment

—

Countries

Austria

Contacts

Public ContactNephrology and Dialysis

Medical University of Vienna

johannes.kovarik@meduniwien.ac.at0043436766108177

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026