Early Diabetic Nephropathy, Hypertension
Conditions
Keywords
valsartan, lisinopril, albuminuria, diabetic nephropathy
Brief summary
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up. Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients. Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies.. Design: Multicentric, randomized, open label, parallel group, active controlled. Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20 Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks. Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.
Interventions
DRUGVALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Inclusion criteria
* Male or female outpatients aged 40-75 years, * Chronic nephropathy, as defined by a serum creatinine concentration of \> 1.3 mg/dL or calculated glomerular filtration rate of \> 30 mL/min/1.73 m2. * Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not \> 1000 mg/ 24h. (for a minimum of three months). * Hypertensive patients not adequately controlled with or without treatment (controlled: \<130/80 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 or nephrotic syndrome. * Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs. * Albuminuria greater than 1000mg /24h and or less than 20mg/24h. * Total cholesterol \< 135mg/dl or not need for statins treatment. * 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 umol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urine albumin excretion rate from collected urine samples, after 16 and 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment | — |
| Change from baseline 48-hour ambulatory blood pressure, and blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment | — |
| Blood pressure less than 130/80 mmHg at night, measured by 48-hour ambulatory blood pressure monitoring, after 16 and 20 weeks of treatment | — |
| Change from baseline in size of left heart ventricle by electrocardiogram (ECG) after 20 weeks | — |
| Change from baseline in kidney function after 16 and 20 weeks | — |
Countries
Switzerland
Outcome results
None listed