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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00338091
Recruitment Status : Terminated
First Posted : June 20, 2006
Last Update Posted : June 20, 2006
Information provided by:
Southern Medical University, China

Brief Summary:
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 or disease Intervention/treatment Phase
Renal Insufficiency,Chronic Disease Progression Proteinuria Dose-Response Relationship,Drug ACE Inhibitor Angiotensin II Type 1 Receptor Blockers Drug: Benazepril Drug: Losartan Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2002
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
  2. 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
  3. nondiabetic renal disease
  4. 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:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00338091

China, Guangdong
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Southern Medical University, China
Principal Investigator: Fan Fan Hou, M.D.,Ph.D. Division of Nephrology, Nanfang Hospital,Southern Medical University,China Identifier: NCT00338091     History of Changes
Other Study ID Numbers: ROAD
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: June 20, 2006
Last Verified: January 2002

Keywords provided by Southern Medical University, China:
Renal Insufficiency,Chronic
Disease Progression
Dose-Response Relationship,Drug

Additional relevant MeSH terms:
Disease Progression
Renal Insufficiency
Renal Insufficiency, Chronic
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors