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)
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1
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, Netherlands
2
University Medical Center Nijmegen St Radboud
Nijmegen, Netherlands, 6525 GA