Eplerenone, Sodium restriction, hydroChlorothiazide, and ACE-inhibition in Proteinuria Evaluated.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27384

Enrollment

Registered

2009-12-04

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

kidney disease diabetes mellitus albuminuria proteinuria hypertension aldosterone blockade ACE inhibition diuretic therapy dietary sodium restriction

Interventions

Combinations of: 1. Lisinopril 40 mg/d

2. Hydrochlorothiazide 50 mg/d

3. Eplerenone 25-50 mg/d

4. Normal diet

5. Sodium restricted diet. Patients will be randomised into 4 groups, alike the DiNaMo study (the ESCAPE study is an addendum to the DiNaMo study). The ESCAPE study consists of 2 study periods of 6 w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diabetic nephropathy; 2. Diabetes mellitus type II; 3. Proteinuria 30 mL/min; 5. Age ≥ 18 years.

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus type I; 2. Myocardial infarction or other cardiovascular event within the last 3 months prior to entry into the study; 3. Kidney disease other than caused by diabetes mellitus or hypertension; 4. Uncontrollable hypertension after the run- in period (>180/100 mmHg); 5. Serum potassium > 6.0 mmol/L; 6. Incompliance with regard to study medication or diet; 7. Unable to give informed consent; 8. Contraindication for the use of lisinopril or eplerenone.

Design outcomes

Primary

Measure	Time frame
1. Albuminuria; 2. Blood pressure.	—

Secondary

Measure	Time frame
1. Tubular injury markers; 2. Extracellular fluid volume.	—

Contacts

Public ContactG.D. Laverman

Hanzeplein 1

g.d.laverman@int.umcg.nl+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)