drugset / Trial / NCT05996835

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

NCT05996835 ↗

Phase 2 Completed 316 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2024-01-18
Primary completion
2026-02-25
Completion
2026-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject TIN816 Protein / enzyme biologic 70 mg Intravenous

Indications