Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT00419835 |
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Recruitment Status :
Completed
First Posted : January 9, 2007
Last Update Posted : August 4, 2011
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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
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Macroalbuminuric Diabetic Nephropathy | Drug: enalapril Drug: losartan | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | September 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Primary Outcome Measures :
- effect of treatment on proteinuria after 8 months of follow-up
Secondary Outcome Measures :
- effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
- incidence of hyperkalemia
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diabetic nephropathy characterised by a daily proteinuria superior to 500 mg
- type II diabetes
Exclusion Criteria:
- type 1 diabetes
- serum creatinine > 2.5 mg/dL or creatinine clearance lower than 30 ml/min
- serum potassium > 5.5 mEq/L
- intolerance or allergy to ACE inhibitors or BRA
- pregnancy
- hepatitis C or B
- HIV
- current chemotherapy treatment
Information from the National Library of Medicine
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): NCT00419835
Locations
| Brazil | |
| Nephrology Department, Sao Paulo University Medical School | |
| Sao Paulo, Brazil, 05403-010 | |
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
| Study Director: | Roberto Zatz, Full Professor of Nephrology | Nephrology Department, Sao Paulo University Medical School |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00419835 |
| Other Study ID Numbers: |
ST01 |
| First Posted: | January 9, 2007 Key Record Dates |
| Last Update Posted: | August 4, 2011 |
| Last Verified: | January 2007 |
Keywords provided by University of Sao Paulo:
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diabetic nephropathy proteinuria CKD progression dialysis |
Additional relevant MeSH terms:
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Kidney Diseases Diabetic Nephropathies Proteinuria Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Diabetes Complications Urination Disorders |
Urological Manifestations Losartan Enalapril Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |