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临床试验/NCT02530359
NCT02530359Unknown4 期

Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury

Hospital Civil de Guadalajara0 个研究点目标入组 90 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
90
主要终点
renal function recovery

研究概览

简要总结

Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a primary objective.

详细描述

Septic acute kidney injury (AKI) is the most common cause of AKI in the world, there is no specific treatment for this pathology; the pathophysiology is related to inflammatory pathway and strategies that modulate this are potentially useful. The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment, in animal models has shown a beneficial effect on the recovery of renal function immediately after administrated. The investigators propose a triple blind clinical trial,in which septic AKI patients will be randomized in three arms, all receive conventional treatment KDIGO guides, groupPDF 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days. The Investigators analyze the recovery of renal function as a primary objective, as a secondary objectives clinical variables associated with renal recovery, biochemical variables, inflammatory, molecular variables and measurement of PDF in blood will be analyzed. Patients will be follow-up for 7 days and 28 days after randomization.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine <2 mg / dL)

排除标准

  • Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine > 2mg/dl) known and / or sharpened.
  • chronic dialysis (peritoneal dialysis or hemodialysis)
  • History of AKI and / or RRT in the last three months
  • Pregnancy AKI by other causes other than sepsis

研究组 & 干预措施

Group 1

Active Comparator

Pirfenidone extended release 600mg per mouth every 12 hours for 7 days.

干预措施: Pirfenidone extended release (Drug)

Group 2

Active Comparator

Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.

干预措施: Pirfenidone extended release (Drug)

Group 2

Active Comparator

Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.

干预措施: Placebo equivalent (Drug)

Group 3

Placebo Comparator

Placebo equivalent per mouth every 12 hrs for 7 days.

干预措施: Placebo equivalent (Drug)

结局指标

主要结局

renal function recovery

时间窗: within the first 28 days

serum creatinine in serum \<2mg/dl and urinary output \>1,200ml/day

次要结局

  • Urinary Volume(within the first 7 days)
  • serum urea levels(within the first 7 days)
  • pirfenidone levels in serum ug/mL(on day 1 and day 7)
  • need of renal replacement therapy (RRT)(within the first 7 days)
  • mortality(within the first 7 days)
  • serum creatinine levels(within the first 7 days)
  • IL-1(on day 1 and day 7)
  • IL-6(on day 1 and day 7)
  • TNF-α(on day 1 and day 7)
  • Toll-like receptor 4(on day 1 and day 7)

研究者

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

Jonathan Samuel Chavez Iñiguez

Nephrologhist

Hospital Civil de Guadalajara

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