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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Spironolactone

Intervention Type DRUG

Irbesartan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gavin G Becker, MBBS MD

Role: STUDY_DIRECTOR

Director Department of Nephrology, The Royal Melbourne Hospital

Locations

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Department of Nephrology, The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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Chrysostomou A, Becker G. Spironolactone in addition to ACE inhibition to reduce proteinuria in patients with chronic renal disease. N Engl J Med. 2001 Sep 20;345(12):925-6. doi: 10.1056/NEJM200109203451215. No abstract available.

Reference Type BACKGROUND

PMID: 11565535 (View on PubMed)

Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

Reference Type DERIVED

PMID: 33107592 (View on PubMed)

Other Identifiers

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RMH2001-142

Identifier Type: -

Identifier Source: org_study_id