跳至主要内容
临床试验/NCT02190318
NCT02190318Unknown不适用

The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients

Second Xiangya Hospital of Central South University0 个研究点目标入组 96 人开始时间: 2013年11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
发起方
入组人数
96
主要终点
residual renal function of peritoneal dialysis patients

研究概览

简要总结

Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.

详细描述

Residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients. It is now recognized as an important factor in the prognosis of PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone antagonist.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who having been on PD continuously for one month, urine volume>600 ml/d, residual renal function>2ml/min/1.73m2, blood pressure>120/70mmHg, serum potassium levels<5.5mmol/l, stable clinical condition.

排除标准

  • Patients with infectious systemic disease, peritonitis during the preceding 1 month, who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within the preceding 6 months.

研究组 & 干预措施

Losartan

Experimental

Losartan is taken orally 100mg/d

干预措施: Losartan (Drug)

spirolactone

Experimental

spirolactone is taken orally 20mg/d

干预措施: spirolactone (Drug)

losartan in combination with spirolactone

Experimental

Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d

干预措施: Losartan (Drug)

losartan in combination with spirolactone

Experimental

Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d

干预措施: spirolactone (Drug)

blank control

Sham Comparator

patients with antihypertensives besides ACEI/ARBs and spirolactone.

干预措施: blank control (Other)

结局指标

主要结局

residual renal function of peritoneal dialysis patients

时间窗: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.

次要结局

  • peritoneal membrane function(From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.)

研究者

发起方
Second Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Liu

deputy director of nephrology department

Second Xiangya Hospital of Central South University

相似试验