drugset / Trial / NCT05507437

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

NCT05507437 ↗

Phase 2 Completed 20 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2022-11-22
Primary completion
2024-04-25
Completion
2024-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject TIN816 Protein / enzyme biologic 70 mg Intravenous

Indications