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ISRCTN
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ISRCTN47438148
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ClinicalTrials.gov identifier
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NCT00338091
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Public title
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Renoprotection of Optimal Antiproteinuric Doses of benazepril and losartan in chronic renal insufficiency: long-term analysis
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Scientific title
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Acronym
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ROAD
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Serial number at source
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30330300
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Study hypothesis
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The primary hypothesis is the optimal antiproteinuric doses of benazepril (an Angiotensin-Converting Enzyme [ACE] inhibitor) or losartan (an Angiotensin II Receptor Blocker [ARB]), as compared with their conventional doses, can safely improve the long-term renal outcome in non-diabetic patients with proteinuria and chronic renal insufficiency. The second hypothesis is that long-term renoprotection of benazepril and losartan, at their optimal antiproteinuric doses, might be similar.
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Lay summary
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Ethics approval
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Nanfang Ethics Committee (reference number: 200201).
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Study design
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Randomised open-label parallel-assignment safety/efficacy study
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Countries of recruitment
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China
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Disease/condition/study domain
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Nondiabetic Chronic Renal Insufficiency
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Participants - inclusion criteria
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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])
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2002
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Anticipated end date
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01/05/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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360 participants
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Interventions
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Each intervention group will be given one of the following treatments:
Drug 1: benazepril
Drug 2: losartan
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. People’s Liberation Army Grant for Major Clinical Research (2001, to Dr. Fan Fan Hou)
2. National Nature and Sciences Grant for Major Projects (No.30330300, to Dr. Fan Fan Hou)
3. Novartis (in part)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17494885
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Contact name
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Prof
Fan Fan
Hou
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Address
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1838 North Guangzhou Avenue
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City/town
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Guangzhou
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Zip/Postcode
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510515
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Country
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China
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Tel
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+86 (0) 20 6164 1597
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Fax
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+86 (0) 20 8728 1713
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Email
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ffhou@public.guangzhou.gd.cn
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Sponsor
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National Nature and Sciences Grant Committee (China)
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Address
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83 Shuangqing Road
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City/town
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Beijing
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Zip/Postcode
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100085
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Country
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China
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Sponsor website:
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http://www.nsfc.gov.cn
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Date applied
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30/08/2006
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Last edited
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24/09/2009
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Date ISRCTN assigned
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04/09/2006
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