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

This study has been terminated.
Sponsor:
Information provided by:
Southern Medical University, China
ClinicalTrials.gov Identifier:
NCT00338091
First received: June 16, 2006
Last updated: NA
Last verified: January 2002
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 01, 2014