跳至主要内容
临床试验/NCT02687841
NCT02687841Unknown3 期

A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
206
试验地点
1
主要终点
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.

研究概览

简要总结

Hospital acquired acute kidney injury is an important negative outcome predictor for hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these uremic toxins are protein bound and may accumulated after renal impairment, owing to both impaired filtration, and inflammation. Recent animal studies have reported that accumulation of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic toxins with an activated charcoal would help restore endothelial function. We will conduct a double blinded randomized placebo controlled trial, which aims to determine that if oral activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial function will also be determined.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

AST-120 and PTX

Experimental

AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days Pentapentoxifylline 400mg QD for 10 days

干预措施: AST-120and pentoxyphylline (PTX) (Drug)

PTX

Active Comparator

Pentapentoxifylline 400mg QD for 10 days

干预措施: pentoxyphylline (PTX) (Drug)

结局指标

主要结局

Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.

时间窗: 10 days

次要结局

  • Total recovery of serum creatinine on Day 5(5 days)
  • Needing renal replacement therapy on day 10.(10 days)
  • Degree of serum creatinine elevation(10 days)
  • The degree of Indoxyl sulfate change on Day 10 (%)(10 days)
  • The degree of Indoxyl sulfate change on Day 5 (%)(5 days)
  • The degree of p-cresol change on Day 10 (%)(10 days)
  • The degree of p-cresol change on Day 5 (%)(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Hospital

KWAN-DUN WU MD. PhD.

National Taiwan University Hospital

研究点 (1)

Loading locations...

相似试验