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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00106561
Other study ID # RMH2001-142
Secondary ID
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
Est. primary completion date
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


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
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