Renal Insufficiency,ChronicNCT00338091
Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
A study testing Benazepril and Losartan in people with Renal Insufficiency,Chronic and Disease Progression, run by Southern Medical University, China at 1 site in China.
Trial summary
The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Insufficiency,Chronic, Disease Progression, Proteinuria
- What is being tested?
- Benazepril and Losartan
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jan 2002to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
- Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
- nondiabetic renal disease
- 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])
Who cannot join
- Immediate need for dialysis
- Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
- Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- Renovascular disease
- Myocardial infarction or cerebrovascular accident in the year preceding the trial
- Connective-tissue disease; and obstructive uropathy
Trial locations and contacts
1 site in 1 country.
China1 site
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, 510515
About this study
The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.
- Conditions
- Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, ACE Inhibitor, Angiotensin II Type 1 Receptor Blockers
- Being tested
- Benazepril, Losartan
- Keywords
- Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, Benazepril, Losartan
- Medical subject headings
- Renal Insufficiency, Chronic, Disease Progression, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenazeprilDrug
LosartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.
Secondary outcomes (1)
Secondary endpoints included changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and glomerular filtration rate as calculated by Modification of Diet in Renal Disease equation-4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJan 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency,ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Fan Fan Hou, M.D.,Ph.D., Principal investigator, Division of Nephrology, Nanfang Hospital,Southern Medical University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338091
- Sponsor's protocol ID
- ROAD
- Status last verified
- Jan 2002
- First submitted
- 16 Jun 2006
- Last updated
- 20 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00338091
- Acronym / sponsor ID
- ROAD
- Conditions
- Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, ACE Inhibitor, Angiotensin II Type 1 Receptor Blockers
- Keywords
- Renal Insufficiency,Chronic, Disease Progression, Proteinuria, Dose-Response Relationship,Drug, Benazepril, Losartan
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- May 2006
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
- Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
- nondiabetic renal disease
- 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 (6 listed)
- Immediate need for dialysis
- Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
- Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- Renovascular disease
- Myocardial infarction or cerebrovascular accident in the year preceding the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benazepril | Drug | – |
| Losartan | Drug | – |
Primary outcome
The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.
1 secondary outcome
Secondary endpoints included changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and glomerular filtration rate as calculated by Modification of Diet in Renal Disease equation-4.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2006.
Related trials for Renal Insufficiency,Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Fan Hou, M.D.,Ph.D. principal investigator
Division of Nephrology, Nanfang Hospital,Southern Medical University,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benazepril and Losartan in people with Renal Insufficiency,Chronic and Disease Progression, run by Southern Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2006.