Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury

  • STATUS
    Not Recruiting
  • participants needed
    120
  • sponsor
    Atox Bio Ltd
Updated on 4 August 2021
Investigator
David Wilfret, MD
Primary Contact
Maricopa Medical Center (4.4 mi away) Contact
+47 other location
laparotomy
sepsis
antibiotic therapy
antibiotics
renal injury
0.9% sodium chloride
abdominal infection
interventional radiologic procedures
0.9% sodium chloride injection
reltecimod

Summary

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

Description

Phase 3 randomized, placebo controlled study assessing the efficacy (complete recovery from AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis (planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures for control of underlying abdominal infection within 24 hours of evaluation by medical personnel) or patients with surgically confirmed necrotizing soft tissue infection (NSTI), requiring intensive care unit (ICU) or step down unit admission and in whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis or from surgically confirmed diagnosis of NSTI.

Details
Condition Peritonitis, Acute renal failure, Necrotizing Soft Tissue Infection
Treatment 0.9% Sodium Chloride Injection, Reltecimod
Clinical Study IdentifierNCT03403751
SponsorAtox Bio Ltd
Last Modified on4 August 2021

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