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

NCT00338091 | Terminated

• 1 other identifier: ROAD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Benazepril DRUG

Losartan DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[a New York Heart Association class of Ⅲ or Ⅳ\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Renal Division, Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Disease Progression; Proteinuria

Interventions

benazepril; Losartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Fan Fan Hou, M.D.,Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: January 1, 2002
• Study Completion: May 1, 2006
• Last Updated: June 20, 2006

Record last verified: 2002-01

Locations

CN (1)