Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Matthieu Legrand
Headshot of Matthieu Legrand
Matthieu Legrand

Description

Summary

The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Four-arm, Parallel-group, Dose-finding Phase 2b Study to Investigate the Safety and Efficacy of TIN816 Via a Single Intravenous Infusion in the Treatment of Participants With Sepsis-associated Acute Kidney Injury (SA-AKI)

Details

This is a multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study. The study will enroll hospitalized adult participants with a diagnosis of sepsis and acute kidney injury (AKI). The study consists of a screening period (24-48 hours), a treatment period (Day 1), and post-treatment period (Day 2 to 90). Screening will take place during hospitalization in ICU (or intermediate care unit/HDU) where potential participants will undergo screening to assess the presence of sepsis and AKI. At Treatment Day 1, participants who meet eligibility criteria at screening and baseline will be randomized in a 3:1:1:3 ratio to receive a one-time treatment of TIN816 or placebo by intravenous infusion in a participant and investigator-blinded fashion. Treatment Day 1 is followed by a 90-day post-treatment period for safety and efficacy assessments. An interim analysis (IA) is planned when approximately 120 participants complete Day 30 visit. A final analysis will be performed after all participants have completed Day 90.

Keywords

Acute Kidney Injury Due to Sepsis, Sepsis, acute kidney injury, anti-inflammatory, immunosuppression, intensive care unit, Toxemia, Wounds and Injuries, TIN816 70 mg lyophilisate powder

Eligibility

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143-0116 United States
  • Stanford Healthcare accepting new patients
    Stanford California 94305 5152 United States

Lead Scientist at UCSF

  • Matthieu Legrand
    Dr. Legrand is a clinician scientist practicing critical care medicine and anesthesiology. His professional interests include the use of cardiovascular medications in critical illness and major surgery, treatments and pathophysiology of sepsis, and acute kidney injury.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05996835
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 320 study participants
Last Updated