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临床试验/NCT07161843
NCT07161843尚未招募2 期

Determine the Efficacy of Investigational Drug QRX-3 in Hospitalized Patients With Acute Tubular Necrosis Pattern of Acute Renal Failure

Ebima Clifford Okundaye1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
Rate of change in creatinine glomerular filtration rate

研究概览

简要总结

Use of QRX-3 in hospitalized patients with pediatric and adult patients with acute tubular necrosis renal failure

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients
  • presence of Acute renal failure
  • Nephrologist diagnosis of Acute tubular necrosis or fractional excretion of sodium of >2%
  • willingness to participate

排除标准

  • High risk of bleeding Absence of hydronephrosis or obstructive uropathy Absence of baseline dialysis use single kidney status

研究组 & 干预措施

Use of QRX-3 in addition to standard therapy

Experimental

QRX-3 drug orally as twice daily in addition to standard conventional therapy will be given to this group for 28 days

干预措施: QRX-3 (Drug)

control group

Placebo Comparator

placebo twice daily will be given to this group in addition to standard therapy

干预措施: QRX-3 (Drug)

结局指标

主要结局

Rate of change in creatinine glomerular filtration rate

时间窗: 28 days

compare the outcome effect of added QRX-3 drug to placebo in addition to standard therapy on the rate of change from baseline of creatinine GFR in ATN patients

次要结局

  • daily change in glomerular filtration rate in ml/min(7 days)
  • daily change in cystatin C level in mg/dl(7 days)

研究者

发起方
Ebima Clifford Okundaye
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Ebima Clifford Okundaye

President

Neukidney Inc.

研究点 (1)

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