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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00721773
First received: July 22, 2008
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Renal Function Disorder
Drug: Benazepril
Drug: Valsartan
Drug: Benazepril+Valsartan
Drug: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The longitudinal change in residual glomerular filtration rate (GFR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.


Secondary Outcome Measures:
  • Dialysis adequacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection.

  • Peritoneal membrane function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Peritoneal membrane function assessed by standard peritoneal equilibration test.

  • Blood pressure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Office systolic and diastolic blood pressure measurement during follow up period.

  • The time to anuria [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Anuria is defined as urine volume < 100ml/d.

  • Death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Death from any cause.


Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Benazepril group
Experimental: 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.
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.
Other Name: Valsartan group
Experimental: 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.
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.
Other Name: Benazepril plus Valsartan group
Active Comparator: non-RAS inhibitor
Drug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker.
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.
Other Name: Control group

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721773

Contacts
Contact: Xueqing Yu, M.D.& Ph.D. 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Haiping Mao, M.D.& Ph.D. 8620-87755766 ext 8143 haipingmao@126.com

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Xueqing Yu, M.D. & Ph.D.    8620-87766335    yuxq@mail.sysu.edu.cn   
Contact: Haiping Mao, M.D. & Ph.D.    8620-87755766 ext 8143    haipingmao@126.com   
Principal Investigator: Xueqing Yu, M.D.& Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Jianbo Liang, M.D. 2nd Affiliated Hospital, Guangzhou Medical College
Principal Investigator: Yunhua Liao, M.D. 1st Affiliated Hospital, Guangxi Medical University
Principal Investigator: Xinzhou Zhang, M.D. & Ph.D. Shenzhen People's Hospital
Principal Investigator: Fei Xiong, M.D. Wuhan No.1 Hospital
Principal Investigator: Hao Zhang, M.D. 3rd Xiangya Hospital, Central South University
Principal Investigator: Ping Fu, M.D. & Ph.D. West China Hospital
Principal Investigator: Yonggui Wu, M.D.& Ph.D. 1st Affiliated Hospital, Anhui Medical University
Principal Investigator: Minghui Zhao, M.D.&Ph.D. Peking University First Hospital
Principal Investigator: Xuewang Li, M.D. Peking Union Medical College Hospital
Principal Investigator: Li Hao, MD 2nd Affiliated Hospital, Anhui Medical University
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00721773     History of Changes
Other Study ID Numbers: PDRRF
Study First Received: July 22, 2008
Last Updated: September 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Continuous Ambulatory Peritoneal Dialysis
Angiotensin-converting Enzyme Inhibitor
Angiotensin II Receptor Blocker
Renin angiotensin system inhibitor
Residual Renal Function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Benazepril
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014