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...
Date First Received: December 23, 2005
Last Updated: May 4, 2006
Verified by: Southern Medical University, China, March 1999
Clinical Trial Phase: N/A | Start Date:
Overall Status: Terminated
Brief Summary
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Benazepril
Criteria for Participation in this Clinical Trial
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.
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
Clinical Trial Sponsor Information
Lead Sponsor: Southern Medical University, China
Overall Clinical Trial Officials and Contacts
Fan Fan Hou, M.D.,Ph.D. Principal Investigator Southern Medical University
Related Publications
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00270426
Study ID Number: SouthernMUC
ClinicalTrials.gov Identifier: NCT00270426
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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