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Renal Protective Effects of Benazepril and Valsartan in Peritoneal Dialysis Patients
This study is currently recruiting participants.
Verified by Sun Yat-sen University, January 2010
First Received: July 22, 2008   Last Updated: January 29, 2010   History of Changes
Sponsor: Sun Yat-sen University
Information provided by: Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00721773
  Purpose

A prospective, randomized, open-label, multiple-center clinical trial to compare Benazepril and Valsartan combination therapies to Benazepril and Valsartan monotherapy, and control for reducing the rate of residual renal function decline in continuous ambulatory peritoneal dialysis (CAPD) patients.


Condition Intervention
Continuous Ambulatory Peritoneal Dialysis
Drug: Benazepril
Drug: Valsartan
Drug: Benazepril plus Valsartan
Drug: Control

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effects of Benazepril,Valsartan and Benazepril Plus Valsartan 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: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dialysis adequacy, hospitalization, peritonitis episodes, blood pressure, cardiovascular events, any adverse drug effects, death from any cause. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Peritoneal membrane transport characteristics,inflammation state. [ Time Frame: Every 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Drug: Benazepril
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.
2: Active Comparator
Drug: Valsartan
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.
3: Active Comparator
Drug: Benazepril plus Valsartan
Drug: Benazepril plus 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.
4
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.

Detailed Description:

Residual renal function (RRF) has been shown to decline progressively with time on dialysis in both continuous ambulatory peritoneal dialysis (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 angiotensin-converting enzyme inhibition or angiotensin receptor antagonism is a well-established approach for renoprotection in pre-dialysis chronic kidney disease patients. Up to now, only two trials showed that an angiotensin-converting enzyme inhibitor (ACEI), ramipril, and angiotensin II receptor blocker(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 we will perform prospective, randomized, open-label and multiple center study to address long-term effects of ACEI, ARB and combination of ACEI and ARB 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:

  1. All patients received CAPD more than 1 months
  2. Subjects of either sex, 20-75 years old
  3. Residual GFR of 3mL/min per 1.73 m2 or more
  4. With hypertension
  5. No history of taking an ACE inhibitor or angiotensin-receptor blockers for at least 2 month
  6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

  1. Underlying medical conditions, such as congestive heart failure, or therapy with an ACE inhibitor or ARB
  2. Peritonitis or volume overload within the preceding 1 month
  3. Myocardial infarction within the preceding 6 months
  4. Clinically significant valvular disease
  5. Malignant hypertension
  6. History of hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months
  7. 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
  8. History of allergy or intolerance to an ACE inhibitor or ARB
  9. Participation in another clinic trial within 2 weeks prior to screening
  Contacts and Locations
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, Sichuan University
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
Principal Investigator: Zhonghe Li, MD 5th Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Guanxian Liu, MD Hui Zhou Municipal Central Hospital
  More Information

No publications provided

Responsible Party: Sun Yat-sen University ( Xueqing Yu/Director )
Study ID Numbers: PDRRF
Study First Received: July 22, 2008
Last Updated: January 29, 2010
ClinicalTrials.gov Identifier: NCT00721773     History of Changes
Health Authority: China: State Food and Drug Administration

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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan
Protease Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010