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

Sponsored by:	Southern Medical University, China
Information provided by:	Southern Medical University, China
ClinicalTrials.gov Identifier:	NCT00338091

Purpose

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.

Condition	Intervention
Renal Insufficiency,Chronic Disease Progression Proteinuria Dose-Response Relationship,Drug ACE Inhibitor Angiotensin II Type 1 Receptor Blockers	Drug: Benazepril Drug: Losartan

Drug Information available for: Losartan Losartan potassium Benazepril Benazepril hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Primary Outcome Measures:

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 Outcome Measures:

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.

Study Start Date:	January 2002
Estimated Study Completion Date:	May 2006

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 of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
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
nondiabetic renal disease
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 Ⅲ or Ⅳ])

Exclusion Criteria:

Immediate need for dialysis
Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
Renovascular disease
Myocardial infarction or cerebrovascular accident in the year preceding the trial
Connective-tissue disease; and obstructive uropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338091

Locations

China, Guangdong
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510515

Sponsors and Collaborators

Southern Medical University, China

Investigators

Principal Investigator:

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

Division of Nephrology, Nanfang Hospital,Southern Medical University,China

More Information

Study ID Numbers:	ROAD
Study First Received:	June 16, 2006
Last Updated:	June 16, 2006
ClinicalTrials.gov Identifier:	NCT00338091
Health Authority:	China: State Food and Drug Administration

Keywords provided by Southern Medical University, China:

Renal Insufficiency,Chronic
Disease Progression
Proteinuria

Dose-Response Relationship,Drug
Benazepril
Losartan

Study placed in the following topic categories:

Signs and Symptoms
Losartan
Renal Insufficiency
Proteinuria
Urologic Diseases
Urination Disorders

Renal Insufficiency, Chronic
Benazepril
Disease Progression
Kidney Diseases
Angiotensin II

Additional relevant MeSH terms:

Disease Attributes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Urological Manifestations
Pathologic Processes
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 14, 2009