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 is currently recruiting participants.

Verified by University of Sao Paulo, January 2007

First Received: January 8, 2007 No Changes Posted

Sponsors and Collaborators:	University of Sao Paulo 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Kidney Problems

Drug Information available for: Enalapril Enalapril maleate Enalaprilat Losartan Losartan potassium

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

Estimated Enrollment:	80
Study Start Date:	May 2005
Estimated Study Completion Date:	January 2008

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

Contacts

Contact: Silvia MO Titan, PhD student	55-11-5521-6627	silviatitan@superig.com.br
Contact: Roberto Zatz, Full professor of Nephrology		rzatz@usp.br

Locations

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

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

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

Keywords provided by University of Sao Paulo:

diabetic nephropathy
proteinuria
CKD progression
dialysis

Study placed in the following topic categories:

Diabetic Nephropathies
Disease Progression
Signs and Symptoms
Enalapril
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Anti-Arrhythmia Agents
Metabolic Disorder
Diabetes Complications
Losartan
Metabolic Diseases
Urination Disorders

Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Proteinuria
Enalaprilat
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 02, 2009