Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Acute Kidney Injury Due to Sepsis Clinical Trial

Official title: A Participant and Investigator-blinded, Randomized, Placebo-controlled Phase 2a Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Status Completed

Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

Clinical Trial Description

This is a multicenter, participant and investigator-blinded, randomized, placebo-controlled study to characterize PK/PD profile and to evaluate the safety and the tolerability of TIN816. The study will enroll hospitalized adult participants with a diagnosis of sepsis and acute kidney injury (AKI). Approximately 20 participants will be randomized in the study. The study consists of a screening period (24-48 hours), a treatment period (day 1), and post-treatment period (days 2 to 90).

Screening will take place during hospitalization in a intensive care unit (ICU) (or intermediate/high dependency unit (HDU care) where potential participants will undergo screening to assess the presence of sepsis and AKI. Pre-identified participants will provide informed consent and undergo screening assessments to determine eligibility. Potential study candidates will be hospitalized patients with a diagnosis of sepsis based on Sepsis 3 criteria with suspected or confirmed infection and SOFA score ≥ 2 after excluding the renal component, and a diagnosis of AKI stage 1 or greater. At Treatment Day 1, participants who meet eligibility criteria at screening and baseline will be randomized in a 3:1 ratio to treatment with 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 pharmocokinetic, pharmacodynamic, safety and tolerability assessments. ;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis
• Sepsis
• Toxemia
• Wounds and Injuries

• NCT number: NCT05507437
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2022
• Completion date: April 25, 2024