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

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ClinicalTrials.gov Identifier: NCT00106561

Recruitment Status : Completed

First Posted : March 28, 2005

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

Melbourne Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria	Drug: Spironolactone Drug: Irbesartan	Phase 2 Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Prevention
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
Study Start Date :	January 2002
Study Completion Date :	September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Spironolactone Irbesartan

Genetic and Rare Diseases Information Center resources: Glomerulonephritis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

percent reduction in 24 hour urine protein excretion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106561

Locations

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

Sponsors and Collaborators

Melbourne Health

Investigators

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Study Director:	Gavin G Becker, MBBS MD	Director Department of Nephrology, The Royal Melbourne Hospital

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD007004. doi: 10.1002/14651858.CD007004.pub4.

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ClinicalTrials.gov Identifier:	NCT00106561
Other Study ID Numbers:	RMH2001-142
First Posted:	March 28, 2005 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	March 2005

Keywords provided by Melbourne Health:


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

Additional relevant MeSH terms:

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Kidney Diseases Diabetic Nephropathies Proteinuria Glomerulonephritis Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Urination Disorders Urological Manifestations Nephritis Irbesartan	Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

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