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Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00419835
First received: January 8, 2007
Last updated: August 3, 2011
Last verified: January 2007
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

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

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)
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by University of Sao Paulo:
diabetic nephropathy
proteinuria
CKD progression
dialysis

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 17, 2013