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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Macroalbuminuric Diabetic Nephropathy

Intervention / Treatment
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* Drug: enalapril
* Drug: losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: enalapril|nan|
|Drug: losartan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of treatment on proteinuria after 8 months of follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of treatment on urinary inflammatory biomarkers after 8 months of follow-up |  |  | 
| incidence of hyperkalemia |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic nephropathy, proteinuria, CKD progression, dialysis