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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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | January 2008 |
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| Contact: Silvia MO Titan, PhD student | 55-11-5521-6627 | silviatitan@superig.com.br |
| Contact: Roberto Zatz, Full professor of Nephrology | rzatz@usp.br |
| Brazil | |
| Nephrology Department, Sao Paulo University Medical School | Recruiting |
| Sao Paulo, Brazil, 05403-010 | |
| Contact: Silvia Titan, PhD student 55-11-5521-6627 silviatitan@superig.com.br | |
| Contact: Roberto Zatz, Full professor 55-11-3069-6000 ext 7171 rzatz@usp.br | |
| Principal Investigator: Silvia Titan, PhD student | |
| Study Director: | Roberto Zatz, Full Professor of Nephrology | Nephrology Department, Sao Paulo University Medical School |
More Information
| Study ID Numbers: | ST01 |
| Study First Received: | January 8, 2007 |
| Last Updated: | January 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00419835 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
diabetic nephropathy proteinuria CKD progression dialysis |
|
Diabetic Nephropathies Molecular Mechanisms of Pharmacological Action Signs and Symptoms Enalapril Urologic Diseases Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Anti-Arrhythmia Agents Diabetes Complications Losartan Metabolic Diseases Urination Disorders |
Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Urological Manifestations Proteinuria Enalaprilat Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
