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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00270426
Other study ID # SouthernMUC
Secondary ID
Status Terminated
Phase N/A
First received December 23, 2005
Last updated May 4, 2006

Study information

Verified date March 1999
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 purpose of this study is to further determine whether benazepril, could safely slow the progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L)

2. creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation

3. non-diabetic renal disease

4. persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure [New York Heart Association class III–IV]).

Exclusion Criteria:

- immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Benazepril


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Southern Medical University, China

References & Publications (1)

Hou FF, Zhang X, Zhang GH, Xie D, Chen PY, Zhang WR, Jiang JP, Liang M, Wang GB, Liu ZR, Geng RW. Efficacy and safety of benazepril for advanced chronic renal insufficiency. N Engl J Med. 2006 Jan 12;354(2):131-40. — View Citation

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