A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

Summary

This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

Timeline

Start

2023-03-03

Primary completion

2025-03-26

Completion

2025-06-23

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision”

registry analysis (superiority test); TIN816 2 mg/kg vs Placebo; p = 0.4543; geometric mean ratio 0.991 (90% CI 0.87 to 1.13); ANCOVA NCT05524051 ↗

registry analysis (superiority test); TIN816 4 mg/kg vs Placebo; p = 0.8667; geometric mean ratio 1.075 (90% CI 0.97 to 1.20); ANCOVA NCT05524051 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TIN816	Protein / enzyme biologic	2 mg/kg	Intravenous
Subject	TIN816	Protein / enzyme biologic	4 mg/kg	Intravenous

Indications