Renoprotection of Optimal Antiproteinuric Doses of benazepril and losartan in chronic renal insufficiency: long-term analysis

Not Applicable

Completed

• Conditions: ondiabetic Chronic Renal Insufficiency; Urological and Genital Diseases

• Registration Number: ISRCTN47438148
• Lead Sponsor: ational Natural Science Foundation of China

Brief Summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17494885

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2003-05-01
• Study Start: 2006-09-04
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

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 1.73 m^2, 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 litre or more or 3.5 mmol per litre or less)
4. Renovascular disease
5. Myocardial infarction or cerebrovascular accident in the year preceding the trial
6. Connective-tissue disease and obstructive uropathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is time to the first event for the composite endpoint: doubling of the serum creatinine concentration, End Stage Renal Disease (ESRD) or death. Doubling of serum creatinine concentration from the baseline value (mean of all values obtained during the run-in) is confirmed by a second serum creatinine value obtained at least four weeks after the initial doubling. ESRD is defined by the need for long-term dialysis or renal transplantation.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and Glomerular Filtration Rate (GFR) as calculated by Modification of Diet in Renal Disease (MDRD) equation.