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 (NCT) | NCT00338091 |
| Protocol serial number | 30330300 |
| Sponsor | National Natural Science Foundation of China |
| Funders | Peoples Liberation Army Grant for Major Clinical Research (2001, to Dr. Fan Fan Hou), National Nature and Sciences Grant for Major Projects (No.30330300, to Dr. Fan Fan Hou), Novartis (in part) |
- 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
Scientific
1838 North Guangzhou Avenue
Guangzhou
510515
China
| Phone | +86 (0) 20 6164 1597 |
|---|---|
| ffhou@public.guangzhou.gd.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label parallel-assignment safety/efficacy study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Renoprotection of Optimal Antiproteinuric Doses of benazepril and losartan in chronic renal insufficiency: long-term analysis |
| Study acronym | ROAD |
| Study objectives | 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(s) | Nanfang Ethics Committee (reference number: 200201). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Benazepril and losartan |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 360 |
| Key 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]) |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/05/2003 |
Locations
Countries of recruitment
- China
Study participating centre
1838 North Guangzhou Avenue
Guangzhou
510515
China
510515
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
