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	Treatment or Intervention	Phase
Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria	Drug: Spironolactone  Drug: Irbesartan	Phase II Phase III

Further Study Details: 

Primary Outcomes: percent reduction in 24 hour urine protein excretion
Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Australia, Victoria
      Department of Nephrology, The Royal Melbourne Hospital, Melbourne,  Victoria,  3050,  Australia

Study chairs or principal investigators

Gavin G Becker, MBBS MD,  Study Director,  Director Department of Nephrology, The Royal Melbourne Hospital   

Study ID Numbers:  RMH2001-142
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 25, 2005
ClinicalTrials.gov Identifier:  NCT00106561
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08