Eplerenone, ACE Inhibition and Albuminuria

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether eplerenone is more effective than doubling the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Eplerenone; Fosinopril; Spironolactone

Criteria

Inclusion Criteria:

• documented diabetic renal disease with albuminuria >0.020 g/L, stable renal function (i.e. increase of serum creatinine <25% / 6 months), creatinine clearance > 40 ml/min/1.73 m2 , in spite of maximal ACE-inhibition (40 mg fosinopril/day)

• blood pressure < 140/90 mm Hg ( at baseline)

• serum potassium < 5.0 mmol/l (at baseline).

Exclusion Criteria:

• use of NSAID's or immunosuppressive drugs

• use of ARBs, intolerance for ACE inhibition.

• use of diuretics that increase potassium such as triamterene, spironolactone or eplerenone

• pregnancy

• rash or cough on one on the drugs

• severe heart disease or instable angina