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

March 25, 2005
June 23, 2005
January 2002
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percent reduction in 24 hour urine protein excretion
Same as current
Complete list of historical versions of study NCT00106561 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Kidney Disease
  • Diabetic Nephropathy
  • Glomerulonephritis
  • Proteinuria
  • Drug: Spironolactone
  • Drug: Irbesartan
Not Provided
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2004
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00106561
RMH2001-142
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Melbourne Health
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Study Director: Gavin G Becker, MBBS MD Director Department of Nephrology, The Royal Melbourne Hospital
Melbourne Health
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP