Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency

Sponsor

Southern Medical University, China (Other)

Overall Status

Terminated

CT.gov ID

NCT00338091

Collaborator

(none)

Location

51.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency,Chronic Disease Progression Proteinuria Dose-Response Relationship,Drug ACE Inhibitor Angiotensin II Type 1 Receptor Blockers	Drug: Benazepril Drug: Losartan	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2002

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
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
nondiabetic renal disease
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:

Immediate need for dialysis
Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
Renovascular disease
Myocardial infarction or cerebrovascular accident in the year preceding the trial
Connective-tissue disease; and obstructive uropathy