Back to resultsLong-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
Primary Purpose
Renal Insufficiency,Chronic, Disease Progression, Proteinuria
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Benazepril
Losartan
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency,Chronic focused on measuring Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, Benazepril, Losartan
Eligibility 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
Sites / Locations
- Renal Division, Nanfang Hospital,Southern Medical University
Outcomes
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.
Full Information
NCT ID
NCT00338091
First Posted
June 16, 2006
Last Updated
June 16, 2006
Sponsor
Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT00338091
Brief Title
Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2002
Overall Recruitment Status
Terminated
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Southern Medical University, China
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, ACE Inhibitor, Angiotensin II Type 1 Receptor Blockers
Keywords
Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, Benazepril, Losartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Benazepril
Intervention Type
Drug
Intervention Name(s)
Losartan
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Fan Hou, M.D.,Ph.D.
Organizational Affiliation
Division of Nephrology, Nanfang Hospital,Southern Medical University,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal Division, Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Learn more about this trial
Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
We'll reach out to this number within 24 hrs