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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Irbesartan; Spironolactone

Criteria

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