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| Sponsored by: |
Melbourne Health |
|---|---|
| Information provided by: | Melbourne Health |
| ClinicalTrials.gov Identifier: | NCT00106561 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria |
Drug: Spironolactone Drug: Irbesartan |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | September 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | RMH2001-142 |
| Study First Received: | March 25, 2005 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00106561 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
spironolactone proteinuria angiotensin converting enzyme inhibitor |
angiotensin receptor blocker renin angiotensin aldosterone system aldosterone |
|
Glomerulonephritis Diabetic Nephropathies Hormone Antagonists Diuretics Irbesartan Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Signs and Symptoms Urologic Diseases Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Diabetes Complications Urination Disorders |
Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Angiotensin II Antihypertensive Agents Spironolactone Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Proteinuria Aldosterone Antagonists Nephritis Endocrinopathy |
|
Glomerulonephritis Diabetic Nephropathies Molecular Mechanisms of Pharmacological Action Hormone Antagonists Diuretics Physiological Effects of Drugs Irbesartan Hormones, Hormone Substitutes, and Hormone Antagonists Signs and Symptoms Urologic Diseases Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Diabetes Complications Urination Disorders |
Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Spironolactone Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Urological Manifestations Proteinuria Aldosterone Antagonists Natriuretic Agents Nephritis |