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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

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ClinicalTrials.gov Identifier: NCT00419835
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

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

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.

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
Primary Completion Date : September 2007
Study Completion Date : September 2007





Primary Outcome Measures :
  1. effect of treatment on proteinuria after 8 months of follow-up

Secondary Outcome Measures :
  1. effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
  2. incidence of hyperkalemia


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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     History of Changes
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:
diabetic nephropathy
proteinuria
CKD progression
dialysis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms
Losartan
Enalapril
Enalaprilat
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