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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00721773 |
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 |
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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 |
Estimated Enrollment: | 240 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Drug: Benazepril
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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 130/80 mmHg.
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2: Active Comparator
Drug: Valsartan
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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 130/80 mmHg.
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3: Active Comparator
Drug: Benazepril plus Valsartan
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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 130/80 mmHg.
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4
Drug: antihypertensive agents, except ACE inhibitors and ARBs. Administration of antihypertensive agents will select as follows: CCB→β-blocker→α-blocker.
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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 130/80 mmHg.
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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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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. |
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 |
Responsible Party: | Sun Yat-sen University ( Xueqing Yu/Director ) |
Study ID Numbers: | PDRRF |
Study First Received: | July 22, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00721773 |
Health Authority: | China: State Food and Drug Administration |
Continuous Ambulatory Peritoneal Dialysis Angiotensin-converting Enzyme Inhibitor Angiotensin II Receptor Blocker Residual Renal Function |
Benzocaine Benazepril Angiotensin II Valsartan |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |