Condition category
Urological and Genital Diseases
Date applied
30/08/2006
Date assigned
04/09/2006
Last edited
24/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nsfc.gov.cn

Funders

Funder type

Government

Funder name

People’s 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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

Additional files

Editorial Notes