Contact information
Type
Scientific
Primary contact
Prof Fan Fan Hou
ORCID ID
Contact details
1838 North Guangzhou Avenue
Guangzhou
510515
China
+86 (0) 20 6164 1597
ffhou@public.guangzhou.gd.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00338091
Protocol/serial number
30330300
Study information
Scientific title
Acronym
ROAD
Study hypothesis
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.
Ethics approval
Nanfang Ethics Committee (reference number: 200201).
Study design
Randomised open-label parallel-assignment safety/efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nondiabetic Chronic Renal Insufficiency
Intervention
Each intervention group will be given one of the following treatments:
Drug 1: benazepril
Drug 2: losartan
Intervention type
Drug
Phase
Not Specified
Drug names
Benazepril and losartan
Primary outcome measure
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
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.
Overall trial start date
01/01/2002
Overall trial end date
01/05/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360 participants
Participant 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
Recruitment start date
01/01/2002
Recruitment end date
01/05/2003
Locations
Countries of recruitment
China
Trial participating centre
1838 North Guangzhou Avenue
Guangzhou
510515
China
Sponsor information
Organisation
National Nature and Sciences Grant Committee (China)
Sponsor details
83 Shuangqing Road
Beijing
100085
China
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Peoples Liberation Army Grant for Major Clinical Research (2001, to Dr. Fan Fan Hou)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Nature and Sciences Grant for Major Projects (No.30330300, to Dr. Fan Fan Hou)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis (in part)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17494885
Publication citations
-
Results
Hou FF, Xie D, Zhang X, Chen PY, Zhang WR, Liang M, Guo ZJ, Jiang JP, Renoprotection of Optimal Antiproteinuric Doses (ROAD) Study: a randomized controlled study of benazepril and losartan in chronic renal insufficiency., J. Am. Soc. Nephrol., 2007, 18, 6, 1889-1898, doi: 10.1681/ASN.2006121372.