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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00106561
Enrollment
60
Registered
2005-03-28
Start date
2002-01-31
Completion date
2004-09-30
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Glomerulonephritis, Kidney Disease, Proteinuria

Keywords

spironolactone, proteinuria, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, renin angiotensin aldosterone system, aldosterone

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. Interventions that lower protein leak make the kidneys last longer. There are 2 groups of medications, both blood pressure tablets, the ACEI (angiotensin converting enzyme inhibitors) and ATRB (angiotensin receptor blockers) which have shown to reduce the amount of protein leaking from the kidney and as a result lengthen the life of the kidney. There has also been evidence that using these 2 tablets in combination is better than using either one alone. In spite of these tablets, there still remain some patients that continue to leak protein in the urine. Recently there has been evidence that the tablet spironolactone, which is a fluid tablet, also reduces protein leakage from the kidney. In this study we look at various combinations of these tablets to see which works best to lower protein leakage from the kidney. Patients are divided into 4 groups. Each group will receive the tablet ramipril (an ACEI). In group 1, patients will be on ramipril and 2 blank tablets, group 2 will be on ramipril, irbesartan (an ATRB) and a blank tablet, group 3 will be on ramipril, spironolactone and a blank tablet and group 4 will be on ramipril, irbesartan and spironolactone. Protein leakage is measured at the beginning and after 3 months of treatment.

Interventions

DRUGSpironolactone
DRUGIrbesartan

Sponsors

Melbourne Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
percent reduction in 24 hour urine protein excretion

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026