Status:

COMPLETED

Eplerenone, ACE Inhibition and Albuminuria

Lead Sponsor:

Radboud University Medical Center

Conditions:

Diabetic Nephropathy

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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

Detailed Description

In patients with proteinuric renal diseases renal function almost invariably deteriorates, independent from the original renal disease. It has been demonstrated that the rapidity of renal function det...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00315016

Start Date

January 1 2007

End Date

July 1 2011

Last Update

May 28 2012

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

2

University Medical Center Nijmegen St Radboud

Nijmegen, Netherlands, 6525 GA