Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

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. 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. Interventions that lower protein leak make the kidneys last longer.

Official Title

A Double-Blind, Placebo-Controlled Study on the Effect of Spironolactone, in Patients With Persistent Proteinuria on Long-Term Angiotensin Converting Enzyme Inhibitor Therapy, With or With Out an Angiotensin II Receptor Blocker

Conditions

Kidney Disease, Diabetic Nephropathy, Glomerulonephritis, Proteinuria

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures: percentage reduction in 24 hour urine protein excretion

Study Start

January 2002; Study completion: September 2004

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 75 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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 Criteria:

• 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

Total Enrolment

60

Contact Details

Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia

• Published in N Engl J Med