Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
Information source: Southern Medical University, China
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency,Chronic; Disease Progression; Proteinuria; Dose-Response Relationship,Drug; ACE Inhibitor; Angiotensin II Type 1 Receptor Blockers
Intervention: Benazepril (Drug); Losartan (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Southern Medical University, China Official(s) and/or principal investigator(s):
Fan Fan Hou, M.D.,Ph.D., Principal Investigator, Affiliation: Division of Nephrology, Nanfang Hospital,Southern Medical University,China
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Renal Division, Nanfang Hospital,Southern Medical University, Guangzhou, Guangdong 510515, China
Additional Information
Starting date: January 2002
Ending date: May 2006
Last updated: June 16, 2006
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