NCT05507437

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was 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).

Detailed description

This was 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 enrolled hospitalized adult participants with a diagnosis of sepsis and acute kidney injury (AKI). 20 participants were randomized in the study. The study consisted of a screening period (24-48 hours), a treatment period (day 1), and post-treatment period (days 2 to 90). Screening took place during hospitalization in a intensive care unit (ICU) (or intermediate/high dependency unit (HDU care) where potential participants were undergo screening to assess the presence of sepsis and AKI. Pre-identified participants provided informed consent and went to screening assessments to determine eligibility. Potential study candidates were 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 were 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 was followed by a 90 day post-treatment period for pharmocokinetic, pharmacodynamic, safety and tolerability assessments.

Conditions

• Acute Kidney Injury Due to Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	TIN816 70 mg lyophilisate powder	Recombinant human CD39 enzyme
OTHER	Placebo	0.9% sterile sodium chloride solution

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2022-08-19
• Last updated: 2025-12-04
• Results posted: 2025-05-01

Locations

7 sites across 5 countries: Belgium, France, Germany, Hungary, Spain