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临床试验/NCT00721773
NCT00721773已完成不适用

Effects of Benazepril,Valsartan or Combination of Both on Residual Renal Function in Peritoneal Dialysis Patients

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
The longitudinal change in residual glomerular filtration rate (GFR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Benazepril (Drug)

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.

干预措施: Valsartan (Drug)

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.

干预措施: Benazepril+Valsartan (Drug)

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.

干预措施: Control (Drug)

结局指标

主要结局

The longitudinal change in residual glomerular filtration rate (GFR)

时间窗: 3 years

Residual GFR is defined as the average of 24-hour urinary urea and creatinine clearances.

次要结局

  • Dialysis adequacy(3 years)
  • Peritoneal membrane function(3 years)
  • Blood pressure(3 years)
  • The time to anuria(3 years)
  • Number of participants not alive(3 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xue Qing Yu

Professor

Sun Yat-sen University

研究点 (1)

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