Benazepril for Advanced Chronic Renal Insufficiency

This study has been terminated.

First Received on December 23, 2005. Last Updated on May 4, 2006 History of Changes

Sponsor:	Southern Medical University, China
Information provided by:	Southern Medical University, China
ClinicalTrials.gov Identifier:	NCT00270426

Purpose

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.

Condition	Intervention
Chronic Kidney Failure	Drug: Benazepril

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Benazepril hydrochloride Benazepril Lotrel

U.S. FDA Resources

Further study details as provided by Southern Medical University, China:

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L)
creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation
non-diabetic renal disease
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270426

Sponsors and Collaborators

Southern Medical University, China

Investigators

Principal Investigator:

Fan Fan Hou, M.D.,Ph.D.

Southern Medical University

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00270426 History of Changes
Other Study ID Numbers:	SouthernMUC
Study First Received:	December 23, 2005
Last Updated:	May 4, 2006
Health Authority:	China: State Food and Drug Administration

Keywords provided by Southern Medical University, China:

Advanced Chronic Renal Insufficiency
Benazepril

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Benazepril
Angiotensin-Converting Enzyme Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012