Renal Protective Effects of Benazepril and Valsartan in Peritoneal Dialysis Patients
Information source: Sun Yat-sen University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Continuous Ambulatory Peritoneal Dialysis
Intervention: Benazepril (Drug); Valsartan (Drug); Benazepril plus Valsartan (Drug); Control (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s):
Xueqing Yu, M.D. & Ph.D., Principal Investigator, Affiliation: 1st Affiliated Hospital, Sun Yat-Sen University
Jianbo Liang, M.D., Principal Investigator, Affiliation: 2nd Affiliated Hospital, Guangzhou Medical College
Yunhua Liao, M.D., Principal Investigator, Affiliation: 1st Affiliated Hospital, Guangxi Medical University
Xinzhou Zhang, M.D. & Ph.D., Principal Investigator, Affiliation: Shenzhen People's Hospital
Fei Xiong, M.D., Principal Investigator, Affiliation: Wuhan No.1 Hospital
Hao Zhang, M.D., Principal Investigator, Affiliation: 3rd Xiangya Hospital, Central South University
Ping Fu, M.D. & Ph.D., Principal Investigator, Affiliation: West China Hospital, Sichuan University
Yonggui Wu, M.D.& Ph.D., Principal Investigator, Affiliation: 1st Affiliated Hospital, Anhui Medical University
Minghui Zhao, M.D.&Ph.D., Principal Investigator, Affiliation: Peking University First Hospital
Xuewang Li, M.D., Principal Investigator, Affiliation: Peking Union Medical College Hospital
Overall contact:
Xueqing Yu, M.D.& Ph.D., Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
Summary
A prospective, randomized, open-label, multiple-center clinical trial to compare Benazepril
and Valsartan combination therapies to Benazepril and Valsartan monotherapy, and control for
reducing the rate of residual renal function decline in continuous ambulatory peritoneal
dialysis (CAPD) patients.
Clinical Details
Official title: Effects of Benazepril,Valsartan and Benazepril Plus Valsartan on Residual Renal Function in Peritoneal Dialysis Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The longitudinal change in residual glomerular filtration rate (GFR)
Secondary outcome: Dialysis adequacy, hospitalization, peritonitis episodes, blood pressure, cardiovascular events, any adverse drug effects, death from any cause.Peritoneal membrane transport characteristics,inflammation state.
Detailed description:
Residual renal function (RRF) has been shown to decline progressively with time on dialysis
in both continuous ambulatory peritoneal dialysis (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 angiotensin-converting enzyme
inhibition or angiotensin receptor antagonism is a well-established approach for
renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials
showed that an angiotensin-converting enzyme inhibitor (ACEI), ramipril, and angiotensin II
receptor blocker(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 we will perform
prospective, randomized, open-label and multiple center study to address long-term effects
of ACEI, ARB and combination of ACEI and ARB therapy on RRF in Patients on CAPD.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. All patients received CAPD more than 1 months
2. Subjects of either sex, more than 20 years old
3. Residual GFR of 5 mL/min per 1. 73 m2 or more
4. With hypertension
5. No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 2
month
6. Provision of written informed consent by subject or guardian
Exclusion Criteria:
1. Underlying medical conditions, such as congestive heart failure, or therapy with an
ACE inhibitor or ARB
2. Peritonitis or volume overload within the preceding 1 month
3. Myocardial infarction within the preceding 6 months
4. Clinically significant valvular disease
5. Malignant hypertension
6. History of hypertensive encephalopathy or cerebrovascular accident within the
preceding 6 months
7. 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
8. History of allergy or intolerance to an ACE inhibitor or ARB
9. Participation in another clinic trial within 2 weeks prior to screening
Locations and Contacts
Xueqing Yu, M.D.& Ph.D., Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
The 1st Affiliated Hospital, Sun Yet-sen University, GuangZhou, GuangDong 510080, China; Recruiting
Xueqing Yu, M.D. & Ph.D., Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn
Haiping Mao, M.D. & Ph.D., Phone: 8620-87755766, Ext: 8143, Email: haipingmao@126.com
Xueqing Yu, M.D.& Ph.D., Principal Investigator
Additional Information
Starting date: September 2008
Ending date: September 2013
Last updated: March 9, 2009
|
