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Sponsored by: |
Medical University of Gdansk |
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Information provided by: | Medical University of Gdansk |
ClinicalTrials.gov Identifier: | NCT00528385 |
The main purpose of the study is find whether the addition of aldosterone antagonist, spironolactone to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.
Condition | Intervention |
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Chronic Kidney Disease Proteinuria |
Drug: Spironolactone (Spironol) 25 mg |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Influence of Adding Aldosterone Receptor Blocker to Dual Renin-Angiotensin-Aldosterone System Blockade on Proteinuria |
Study Start Date: | March 2005 |
The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a standard renoprotective management at least in patients with nondiabetic proteinuric CKD. However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the progression of CKD completely. Innovative approaches are needed to keep patients with CKD off dialysis. Additional blockade of the aldosterone pathway may prove to be such beneficial therapeutic concept.Aldosterone, a final effector of RAAS plays a significant role in the pathogenesis of CKD independently of angiotensin II through direct cellular action. This includes promoting an inflammatory response, endothelial dysfunction, and fibrosis by increasing plasminogen activator inhibitor (PAI-1) and transforming growth factor beta-1 (TGF-beta-1) expression and stimulation reactive oxygen species.A number of observations suggest nongenomic vasoconstrictor action of aldosterone leading to raise arterial and glomerular capillary pressure.Given these facts additional administration of aldosterone antagonist to combination treatment with ACEI and ARB, so called triple RAAS blockade may provide additional renal protection. To shed more light on this issue, we performed a randomised open controlled study to evaluate the influence of triple RAAS therapy on surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and kidney fibrosis.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | ST-4/RAAS/02 |
Study First Received: | September 11, 2007 |
Last Updated: | September 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00528385 |
Health Authority: | Poland: Ministry of Health |
Proteinuria Renin-Angiotensin-Aldosterone System Aldosterone Antagonists |
Signs and Symptoms Renal Insufficiency Proteinuria Urologic Diseases Urination Disorders Renal Insufficiency, Chronic |
Kidney Failure, Chronic Telmisartan Kidney Diseases Cilazapril Spironolactone Kidney Failure |
Urological Manifestations Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Hormone Antagonists |
Physiological Effects of Drugs Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents Pharmacologic Actions |