Status:
COMPLETED
Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
Lead Sponsor:
Melbourne Health
Conditions:
Kidney Disease
Diabetic Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine which combination of the tablets ramipril, irbesartan or spironolactone is best to lower protein leakage from the kidney.
Detailed Description
Protein leak from the kidney into the urine is an indicator of kidney damage. The higher the leak, the worse the damage and the more likely the patient will lose their kidney function long term. Inter...
Eligibility Criteria
Inclusion
- Proteinuria more than 1.5 g/day
- On ACEI for more than 6 months
- Serum creatinine less than 200 micromol/L with less than 20% variability in the preceeding 3 months
- Creatinine clearance more than 30 ml/min, with less than 20% variability in the preceeding 3 months
Exclusion
- Serum potassium level more than 5 mmol/L
- Treatment with corticosteroids, NSAID or immunosuppressant medication
- Acute myocardial infarction or cerebrovascular accident in the previous 6 months
- Severe uncontrolled hypertension (diastolic \> 115 mmHg or systolic BP \[blood pressure\] \> 220 mmHg)
- Evidence or suspicion of renovascular disease, obstructive uropathy, collagen disease, cancer, drug or alcohol abuse, pregnancy, or breast feeding and ineffective contraception
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00106561
Start Date
January 1 2002
End Date
September 1 2004
Last Update
June 24 2005
Active Locations (1)
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1
Department of Nephrology, The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050