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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE inhibitor, benazepril | Experimental | Benazepril will be started at 10 mg/day and will be up-titrated to 20 mg/day according to BP control and tolerability. |
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| Angiotensin receptor blocker, valsartan | Experimental | Valsartan will be started at 80 mg/day and will be up-titrated to 160 mg/day according to BP control and tolerability. |
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| RAS inhibitors, benazepril+valsartan | Experimental | 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. |
|
| non-RAS inhibitors, control | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benazepril | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The longitudinal change in residual glomerular filtration rate (GFR) | Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis adequacy | Indices of the adequacy of dialysis include Kt/V and weekly creatinine clearance assessed by 24-hour dialysate and urinary collection. | 3 years |
| Peritoneal membrane function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| C044946 | benazepril |
| D000068756 | Valsartan |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Valsartan | 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. |
|
|
| Benazepril+Valsartan | 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. |
|
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| Control | 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. |
|
|
Peritoneal membrane function assessed by standard peritoneal equilibration test.
| 3 years |
| Blood pressure | Office systolic and diastolic blood pressure measurement during follow up period. | 3 years |
| The time to anuria | Anuria is defined as urine volume < 100ml/d. | 3 years |
| Number of participants not alive | Death from any cause. | 3 years |
| Xuewang Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Li Hao, MD | 2nd Affiliated Hospital, Anhui Medical University | Principal Investigator |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |