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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: enalapril
• Drug: losartan

Primary Measures

• effect of treatment on proteinuria after 8 months of follow-up

Secondary Measures

• effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
• incidence of hyperkalemia

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Sao Paulo

Overall Clinical Trial Officials and Contacts

Roberto Zatz, Full Professor of Nephrology Study Director Nephrology Department, Sao Paulo University Medical School  

Overall Contact: Silvia MO Titan, PhD student 55-11-5521-6627 silviatitan@superig.com.br

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419835

Study ID Number: ST01

ClinicalTrials.gov Identifier: NCT00419835

Health Authority: Brazil: National Committee of Ethics in Research