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

This study has been completed.
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00106561
First received: March 25, 2005
Last updated: June 23, 2005
Last verified: March 2005
History of Changes
  Purpose
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 Intervention Phase
Kidney Disease
Diabetic Nephropathy
Glomerulonephritis
Proteinuria
 Drug: Spironolactone
Drug: Irbesartan
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • percent reduction in 24 hour urine protein excretion
Estimated Enrollment: 60
Study Start Date: January 2002
Estimated Study Completion Date: September 2004
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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106561

Locations
Australia, Victoria
Department of Nephrology, The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Study Director: Gavin G Becker, MBBS MD Director Department of Nephrology, The Royal Melbourne Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00106561     History of Changes
Other Study ID Numbers: RMH2001-142 
Study First Received: March 25, 2005
Last Updated: June 23, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
spironolactone
proteinuria
angiotensin converting enzyme inhibitor
 angiotensin receptor blocker
renin angiotensin aldosterone system
aldosterone

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Proteinuria
Glomerulonephritis
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Nephritis
Spironolactone
Irbesartan
 Angiotensin Receptor Antagonists
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
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
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016