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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00338091
Other study ID # ROAD
Secondary ID
Status Terminated
Phase N/A
First received June 16, 2006
Last updated June 16, 2006
Start date January 2002
Est. completion date May 2006

Study information

Verified date January 2002
Source Southern Medical University, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 ? or ?])

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Benazepril

Losartan


Locations

Country Name City State
China Renal Division, Nanfang Hospital,Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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