Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, ACE Inhibitor, Angiotensin II Type 1 Receptor Blockers
Conditions
Keywords
Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, Benazepril, Losartan
Brief summary
The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.
Interventions
DRUGBenazepril
DRUGLosartan
Sponsors
Southern Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L) 2. Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation 3. nondiabetic renal disease 4. Persistent heavier proteinuria (defined by urinary protein excretion of more than 1.0 g per day for three or more months without evidence of urinary tract infection or overt heart failure \[a New York Heart Association class of Ⅲ or Ⅳ\])
Exclusion criteria
1. Immediate need for dialysis 2. Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs 3. Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less) 4. Renovascular disease 5. Myocardial infarction or cerebrovascular accident in the year preceding the trial 6. Connective-tissue disease; and obstructive uropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints included changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and glomerular filtration rate as calculated by Modification of Diet in Renal Disease equation-4. | — |
Countries
China
Outcome results
None listed