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

NCT ID: NCT00721773

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Renal Function Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACE inhibitor, benazepril

Benazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability.

Group Type: EXPERIMENTAL

Benazepril

Intervention Type: DRUG

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.

Angiotensin receptor blocker, valsartan

Valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability.

Group Type: EXPERIMENTAL

Valsartan

Intervention Type: DRUG

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.

RAS inhibitors, benazepril+valsartan

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.

Group Type: EXPERIMENTAL

Benazepril+Valsartan

Intervention Type: DRUG

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.

non-RAS inhibitors, control

Drug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DRUG

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.

Interventions

Benazepril

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.

Intervention Type: DRUG

Valsartan

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.

Intervention Type: DRUG

Benazepril+Valsartan

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.

Intervention Type: DRUG

Control

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.

Intervention Type: DRUG

Other Intervention Names

Benazepril group; Valsartan group; Benazepril plus Valsartan group; Control group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xue Qing Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xueqing Yu, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

1st Affiliated Hospital, Sun Yat-Sen University

Jianbo Liang, M.D.

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, Guangzhou Medical College

Yunhua Liao, M.D.

Role: PRINCIPAL_INVESTIGATOR

1st Affiliated Hospital, Guangxi Medical University

Xinzhou Zhang, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

Fei Xiong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wuhan No.1 Hospital

Hao Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

3rd Xiangya Hospital, Central South University

Ping Fu, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Yonggui Wu, M.D.& Ph.D.

Role: PRINCIPAL_INVESTIGATOR

1st Affiliated Hospital, Anhui Medical University

Minghui Zhao, M.D.&Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Xuewang Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Li Hao, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, Anhui Medical University

Locations

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

PDRRF

Identifier Type: -

Identifier Source: org_study_id