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

Macroalbuminuric Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419835
• Other study ID #: ST01
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2007
• Last updated: August 3, 2011
• Start date: May 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2007
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Macroalbuminuric Diabetic Nephropathy
• Proteinuria

Intervention

Drug:
• enalapril

• losartan

Locations

Country	Name	City	State
Brazil	Nephrology Department, Sao Paulo University Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of treatment on proteinuria after 8 months of follow-up
Secondary	effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up
Secondary	incidence of hyperkalemia