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

NCT ID: NCT00338091

Last Updated: 2006-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Benazepril

Intervention Type DRUG

Losartan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Medical University, China

OTHER

Sponsor Role lead

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Renal Division, Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ROAD

Identifier Type: -

Identifier Source: org_study_id