Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Function Disorder
Intervention: Benazepril (Drug); Valsartan (Drug); Benazepril+Valsartan (Drug); Control (Drug)
Phase: N/A
Status: Completed
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 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 Li Hao, MD, Principal Investigator, Affiliation: 2nd Affiliated Hospital, Anhui Medical University
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.
Clinical Details
Official title: Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The longitudinal change in residual glomerular filtration rate (GFR)
Secondary outcome: Dialysis adequacyPeritoneal membrane function Blood pressure The time to anuria Number of participants not alive
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Locations and Contacts
The 1st Affiliated Hospital, Sun Yet-sen University, GuangZhou, Guangdong 510080, China
Additional Information
Starting date: September 2008
Last updated: May 18, 2015
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