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

ISRCTN ISRCTN47438148
DOI https://doi.org/10.1186/ISRCTN47438148
ClinicalTrials.gov number NCT00338091
Secondary identifying numbers 30330300
Submission date
30/08/2006
Registration date
04/09/2006
Last edited
15/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Fan Fan Hou
Scientific

1838 North Guangzhou Avenue
Guangzhou
510515
China

Phone +86 (0) 20 6164 1597
Email ffhou@public.guangzhou.gd.cn

Study information

Study designRandomised open-label parallel-assignment safety/efficacy study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRenoprotection of Optimal Antiproteinuric Doses of benazepril and losartan in chronic renal insufficiency: long-term analysis
Study acronymROAD
Study objectivesThe 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(s)Nanfang Ethics Committee (reference number: 200201).
Health condition(s) or problem(s) studiedNondiabetic Chronic Renal Insufficiency
InterventionEach intervention group will be given one of the following treatments:
Drug 1: benazepril
Drug 2: losartan
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Benazepril and losartan
Primary outcome measureThe 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 measuresSecondary 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 study start date01/01/2002
Completion date01/05/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants360 participants
Key inclusion criteria1. 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])
Key exclusion criteria1. 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
Date of first enrolment01/01/2002
Date of final enrolment01/05/2003

Locations

Countries of recruitment

  • China

Study participating centre

1838 North Guangzhou Avenue
Guangzhou
510515
China

Sponsor information

National Natural Science Foundation of China
Research organisation

83 Shuangqing Road
Beijing
100085
China

Website http://www.nsfc.gov.cn
ROR logo "ROR" https://ror.org/01h0zpd94

Funders

Funder type

Government

People’s Liberation Army Grant for Major Clinical Research (2001, to Dr. Fan Fan Hou)

No information available

National Nature and Sciences Grant for Major Projects (No.30330300, to Dr. Fan Fan Hou)

No information available

Novartis (in part)
Government organisation / For-profit companies (industry)
Alternative name(s)
Novartis AG, Novartis International AG
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2007 Yes No

Editorial Notes

15/01/2020: Internal review.