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

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106561
• Other study ID #: RMH2001-142
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 25, 2005
• Last updated: June 23, 2005
• Start date: January 2002
• Est. completion date: September 2004

Study information

• Verified date: March 2005
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Glomerulonephritis
• Kidney Disease
• Kidney Diseases
• Proteinuria

Intervention

Drug:
• Spironolactone

• Irbesartan

Locations

Country	Name	City	State
Australia	Department of Nephrology, The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent reduction in 24 hour urine protein excretion