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

Proteinuria Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00338091
• Other study ID #: ROAD
• 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
• 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

Related Conditions & MeSH terms

• ACE Inhibitor
• Angiotensin II Type 1 Receptor Blockers
• Disease Progression
• Dose-Response Relationship,Drug
• Proteinuria
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Renal Insufficiency,Chronic

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.