Antiproteinuric Effect of Valsartan and Lisinopril

Study Overview
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Brief Summary
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Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up. Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients. Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies. Design: Multicentric, randomized, double blind, parallel group, active controlled. Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Official Title
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Antiproteinuric Effect of Valsartan, Lisinopril and Valsartan Plus Lisinopril in Non-diabetic and Diabetic Renal Disease: a Randomized, Double Blind, Parallel Group, Controlled Trial With 5 Months Follow-up

Conditions
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Hypertension, Diabetic Nephropathy

Intervention / Treatment
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* Drug: Valsartan
* Drug: Valsartan plus HCTZ
* Drug: Lisinopril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients aged 18-70 years, Chronic nephropathy, as defined by a serum creatinine concentration of > 3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ). Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg). Written informed consent to participate in the study prior to any study procedures. Exclusion Criteria Immediate need for renal replacement therapy. Treatment resistant oedema. Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs. Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L. Renovascular hypertension Malignant hypertension MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease. Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization. A serum creatinine concentration >265 ümol/L Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan|nan|
|Drug: Valsartan plus HCTZ|nan|
|Drug: Lisinopril|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine protein excretion after 20 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in a laboratory measure of kidney function after 20 weeks |  |  | 
| Change from baseline in systolic blood pressure after 20 weeks |  |  | 
| Change from baseline in diastolic blood pressure after 20 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valsartan, lisinopril, antiproteinuric, diabetic nephropathy