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Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients

Information source: Sun Yat-sen University
Information obtained from ClinicalTrials.gov on February 07, 2013
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: 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
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

Overall contact:
Xueqing Yu, M.D.& Ph.D., Phone: 8620-87766335, Email: yuxq@mail.sysu.edu.cn

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 adequacy

Peritoneal membrane function

Blood pressure

The time to anuria

Death

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

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
Last updated: September 4, 2012

Page last updated: February 07, 2013

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