Renal Function DisorderNCT00721773
Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients
A study testing Benazepril, Valsartan and Benazepril+Valsartan in people with Renal Function Disorder, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicentre study examining the effectiveness of angiotension converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis (CAPD) patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Renal Function Disorder
- What is being tested?
- Benazepril, Valsartan and Benazepril+Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Oct 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients received CAPD more than 1 months
- Subjects of either sex, 20-75 years old
- Residual GFR of 3mL/min per 1.73 m2 or more
- With hypertension
- No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 1 month
- Provision of written informed consent by subject or guardian
Who cannot join
- Underlying medical conditions, such as congestive heart failure, or therapy with an ACE inhibitor or ARB
- Peritonitis or volume overload within the preceding 1 month
- Myocardial infarction within the preceding 6 months
- Clinically significant valvular disease
- Malignant hypertension
- History of hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months
Show all 9Show fewer
- Any condition that may have precluded a patient from remaining in the study, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder
- History of allergy or intolerance to an ACE inhibitor or ARB
- Participation in another clinic trial within 2 weeks prior to screening
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients
This is a multicentre study examining the effectiveness of angiotension converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis (CAPD) patients.
Read the detailed description
RRF has been shown to decline progressively with time on dialysis in both CAPD and hemodialysis. Although RRF is an important determinant of mortality and morbidity in peritoneal dialysis (PD) patients, few studies have addressed therapeutic approaches for preserving RRF after the initiation of dialysis therapy. Blockade of the renin-angiotensin system by ACEI or ARB is a well-established approach for renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials showed that an ACEI, ramipril, and ARB, valsartan , were effective in the preservation of RRF of CAPD patients. However it is important to point out that the evidence cited has limitations. First, the trial only involved patients from one university teaching hospital. Second, transport characteristics, were not assessed before the start of the study. Third, the trial was too small to detect potentially important differences in health care use and survival between groups. Therefore, whether both ACEI and ARB preserve RRF, improve clinical outcomes and decrease health care use and costs should be tested in much longer and larger studies involving multiple sites. In order to confirm these findings, here the investigators will perform prospective, randomized, open-label and multiple center study to address long-term effects of ACEI, ARB and combination of both therapy on RRF in Patients on CAPD.
- Conditions
- Renal Function Disorder
- Being tested
- Benazepril, Valsartan, Benazepril+Valsartan, Control
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, Angiotensin-converting Enzyme Inhibitor, Angiotensin II Receptor Blocker, Renin angiotensin system inhibitor, Residual Renal Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenazeprilDrug
Also called Benazepril group
Patients with hypertension will take 10-20mg benazepril per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
ValsartanDrug
Also called Valsartan group
Patients with hypertension will take 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
Benazepril+ValsartanDrug
Also called Benazepril plus Valsartan group
Patients with hypertension will take 10-20mg benazepril plus 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
ControlDrug
Also called Control group
Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| ACE inhibitor, benazepril | Experimental | Benazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability. Receives: Drug: Benazepril |
| Angiotensin receptor blocker, valsartan | Experimental | Valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability. Receives: Drug: Valsartan |
| RAS inhibitors, benazepril+valsartan | Experimental | Benazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day, and valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability. Receives: Drug: Benazepril+Valsartan |
| non-RAS inhibitors, control | Active comparator | Drug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The longitudinal change in residual glomerular filtration rate (GFR)
Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.
Measured: 3 years
Secondary outcomes (5)
Dialysis adequacy
Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection.
Measured: 3 years
Peritoneal membrane function
Peritoneal membrane function assessed by standard peritoneal equilibration test.
Measured: 3 years
Blood pressure
Office systolic and diastolic blood pressure measurement during follow up period.
Measured: 3 years
The time to anuria
Anuria is defined as urine volume < 100ml/d.
Measured: 3 years
Number of participants not alive
Death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, M.D. & Ph.D., Principal investigator, 1st Affiliated Hospital, Sun Yat-Sen UniversityJianbo Liang, M.D., Principal investigator, 2nd Affiliated Hospital, Guangzhou Medical CollegeYunhua Liao, M.D., Principal investigator, 1st Affiliated Hospital, Guangxi Medical UniversityXinzhou Zhang, M.D. & Ph.D., Principal investigator, Shenzhen People's HospitalFei Xiong, M.D., Principal investigator, Wuhan No.1 HospitalHao Zhang, M.D., Principal investigator, 3rd Xiangya Hospital, Central South UniversityPing Fu, M.D. & Ph.D., Principal investigator, West China HospitalYonggui Wu, M.D.& Ph.D., Principal investigator, 1st Affiliated Hospital, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721773
- Sponsor's protocol ID
- PDRRF
- Status last verified
- May 2015
- First submitted
- 22 Jul 2008
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00721773
- Acronym / sponsor ID
- PDRRF
- Conditions
- Renal Function Disorder
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, Angiotensin-converting Enzyme Inhibitor, Angiotensin II Receptor Blocker, Renin angiotensin system inhibitor, Residual Renal Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 2008 (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.
This is a multicentre study examining the effectiveness of angiotension converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or a combination of both in reducing the rate of decline in residual renal function (RRF) in continuous ambulatory peritoneal dialysis (CAPD) patients.
Detailed description
RRF has been shown to decline progressively with time on dialysis in both CAPD and hemodialysis. Although RRF is an important determinant of mortality and morbidity in peritoneal dialysis (PD) patients, few studies have addressed therapeutic approaches for preserving RRF after the initiation of dialysis therapy. Blockade of the renin-angiotensin system by ACEI or ARB is a well-established approach for renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials showed that an ACEI, ramipril, and ARB, valsartan , were effective in the preservation of RRF of CAPD patients. However it is important to point out that the evidence cited has limitations. First, the trial only involved patients from one university teaching hospital. Second, transport characteristics, were not assessed before the start of the study. Third, the trial was too small to detect potentially important differences in health care use and survival between groups. Therefore, whether both ACEI and ARB preserve RRF, improve clinical outcomes and decrease health care use and costs should be tested in much longer and larger studies involving multiple sites. In order to confirm these findings, here the investigators will perform prospective, randomized, open-label and multiple center study to address long-term effects of ACEI, ARB and combination of both therapy on RRF in Patients on CAPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACE inhibitor, benazepril | Experimental | Drug: BenazeprilBenazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability. |
| Angiotensin receptor blocker, valsartan | Experimental | Drug: ValsartanValsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability. |
| RAS inhibitors, benazepril+valsartan | Experimental | Drug: Benazepril+ValsartanBenazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day, and valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability. |
| non-RAS inhibitors, control | Active comparator | Drug: ControlDrug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients received CAPD more than 1 months
- Subjects of either sex, 20-75 years old
- Residual GFR of 3mL/min per 1.73 m2 or more
- With hypertension
- No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 1 month
Key exclusion criteria (9 listed)
- Underlying medical conditions, such as congestive heart failure, or therapy with an ACE inhibitor or ARB
- Peritonitis or volume overload within the preceding 1 month
- Myocardial infarction within the preceding 6 months
- Clinically significant valvular disease
- Malignant hypertension
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 |
|---|---|---|
| BenazeprilAlso: Benazepril groupPatients with hypertension will take 10-20mg benazepril per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg. | Drug | ACE inhibitor, benazepril |
| ValsartanAlso: Valsartan groupPatients with hypertension will take 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg. | Drug | Angiotensin receptor blocker, valsartan |
| Benazepril+ValsartanAlso: Benazepril plus Valsartan groupPatients with hypertension will take 10-20mg benazepril plus 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg. | Drug | RAS inhibitors, benazepril+valsartan |
| ControlAlso: Control groupPatients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg. | Drug | non-RAS inhibitors, control |
Primary outcome
The longitudinal change in residual glomerular filtration rate (GFR)
Time frame: 3 years
Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.
5 secondary outcomes
Dialysis adequacy
Time frame: 3 years
Peritoneal membrane function
Time frame: 3 years
Blood pressure
Time frame: 3 years
The time to anuria
Time frame: 3 years
Number of participants not alive
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Xueqing Yu, M.D. & Ph.D. principal investigator
1st Affiliated Hospital, Sun Yat-Sen University
Jianbo Liang, M.D. principal investigator
2nd Affiliated Hospital, Guangzhou Medical College
Yunhua Liao, M.D. principal investigator
1st Affiliated Hospital, Guangxi Medical University
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, Valsartan and Benazepril+Valsartan in people with Renal Function Disorder, run by Sun Yat-sen University 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 20 May 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 longitudinal change in residual glomerular filtration rate (GFR) (time frame: 3 years). 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 May 2015.