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| Sponsor: | University of Sao Paulo |
|---|---|
| Collaborator: |
Fundação de Amparo à Pesquisa do Estado de São Paulo |
| Information provided by: | University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00419835 |
Purpose
Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to decrease the rate of progression of this disease and reduce the number of patients needing dialysis or renal transplantation are urgently needed. In this study we wish to compare the effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with diabetic chronic nephropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Macroalbuminuric Diabetic Nephropathy |
Drug: enalapril Drug: losartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus |
| Enrollment: | 80 |
| Study Start Date: | May 2005 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Diabetic kidney disease is the current leading cause of chronic kidney disease (CKD) in the world. Despite all efforts to control this disease, rates of CKD progression are still high and a significant number of patients will ultimately need renal replacement therapy. Pharmacological blockade of renin-angiotensin system is one of the key elements of CKD secondary prevention, and ACE inhibitors or angiotensin II receptor 1 blocker (ARB)can be used for this purpose. However, it is still not clear if dual blockade (ACEi and ARBs simultaneously)is superior to monotherapy with ACE inhibitors or ARBs. A recent trial has suggested that dual blockade is superior to monotherapy in non-diabetic chronic kidney disease. The purpose of this trial is to evaluate the effect of combination therapy compared to ACE inhibitors alone in type 2 diabetic patients with macroalbuminuric diabetic nephropathy.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil | |
| Nephrology Department, Sao Paulo University Medical School | |
| Sao Paulo, Brazil, 05403-010 | |
| Study Director: | Roberto Zatz, Full Professor of Nephrology | Nephrology Department, Sao Paulo University Medical School |
More Information
| ClinicalTrials.gov Identifier: | NCT00419835 History of Changes |
| Other Study ID Numbers: | ST01 |
| Study First Received: | January 8, 2007 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
diabetic nephropathy proteinuria CKD progression dialysis |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Kidney Diseases Proteinuria Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Diabetes Complications Urination Disorders Urological Manifestations Signs and Symptoms Enalapril |
Enalaprilat Losartan Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
