Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
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| ClinicalTrials.gov Identifier: NCT00106561 |
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Recruitment Status :
Completed
First Posted : March 28, 2005
Last Update Posted : June 24, 2005
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria | Drug: Spironolactone Drug: Irbesartan | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | January 2002 |
| Study Completion Date : | September 2004 |
- percent reduction in 24 hour urine protein excretion
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106561
| Australia, Victoria | |
| Department of Nephrology, The Royal Melbourne Hospital | |
| Melbourne, Victoria, Australia, 3050 | |
| Study Director: | Gavin G Becker, MBBS MD | Director Department of Nephrology, The Royal Melbourne Hospital |
Publications:
| ClinicalTrials.gov Identifier: | NCT00106561 History of Changes |
| Other Study ID Numbers: |
RMH2001-142 |
| First Posted: | March 28, 2005 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | March 2005 |
Keywords provided by Melbourne Health:
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spironolactone proteinuria angiotensin converting enzyme inhibitor |
angiotensin receptor blocker renin angiotensin aldosterone system aldosterone |
Additional relevant MeSH terms:
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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 |