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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Benazepril
• Drug: Losartan

Primary 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 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Southern Medical University, China

Overall Clinical Trial Officials and Contacts

Fan Fan Hou, M.D.,Ph.D. Principal Investigator Division of Nephrology, Nanfang Hospital,Southern Medical University,China  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00338091

Study ID Number: ROAD

ClinicalTrials.gov Identifier: NCT00338091

Health Authority: China: State Food and Drug Administration