Clinical trial NCT00721773: Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients
Official title: Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Function Disorder
Keywords: Continuous Ambulatory Peritoneal Dialysis
Angiotensin-converting Enzyme Inhibitor
Angiotensin II Receptor Blocker
Renin angiotensin system inhibitor
Residual Renal Function
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: The longitudinal change in residual glomerular filtration rate (GFR)
timeFrame: 3 years
Secondary outcomes:
measure: Dialysis adequacy
timeFrame: 3 years
measure: Peritoneal membrane function
timeFrame: 3 years
measure: Blood pressure
timeFrame: 3 years
measure: The time to anuria
timeFrame: 3 years
measure: Number of participants not alive
timeFrame: 3 years
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, Guangzhou Medical College
name: Jianbo Liang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 1st Affiliated Hospital, Guangxi Medical University
name: Yunhua Liao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen People's Hospital
name: Xinzhou Zhang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan No.1 Hospital
name: Fei Xiong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 3rd Xiangya Hospital, Central South University
name: Hao Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Ping Fu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 1st Affiliated Hospital, Anhui Medical University
name: Yonggui Wu, M.D.& Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Minghui Zhao, M.D.&Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xuewang Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, Anhui Medical University
name: Li Hao, MD
role: PRINCIPAL_INVESTIGATOR
References: