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

Condition(s) targeted: Macroalbuminuric Diabetic Nephropathy

Intervention: enalapril (Drug); losartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Roberto Zatz, Full Professor of Nephrology, Study Director, Affiliation: Nephrology Department, Sao Paulo University Medical School

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

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.

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

Primary outcome: effect of treatment on proteinuria after 8 months of follow-up

Secondary outcome:

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

incidence of hyperkalemia

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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

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

Nephrology Department, Sao Paulo University Medical School, Sao Paulo 05403-010, Brazil; Recruiting
Silvia Titan, PhD student, Phone: 55-11-5521-6627, Email: silviatitan@superig.com.br
Roberto Zatz, Full professor, Phone: 55-11-3069-6000, Ext: 7171, Email: rzatz@usp.br
Silvia Titan, PhD student, Principal Investigator

Starting date: May 2005
Ending date: January 2008
Last updated: January 8, 2007