Benazepril for Advanced Chronic Renal Insufficiency

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 July 02, 2009

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

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