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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
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. percent reduction in 24 hour urine protein excretion

Eligibility Criteria
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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
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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
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Publications:

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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
Signs and Symptoms
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