NCT05524051

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

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consisted of a pre-operative period (screening visit), a treatment period (Day 1), and a post-treatment follow-up period (Day 2 to Day 90 (EOS)). Participants were followed daily in the hospital from Day 2 to Day 8 as in-patients or at home/nearby accommodation (e.g., hotel or rehabilitation unit if discharged earlier than Day 8), and then as out-patients until the end of the study (Day 30 and Day 90 (EOS) visits).

Conditions

• Acute Kidney Injury Following Cardiac Surgery

Interventions

Type	Name	Description
DRUG	TIN816	TIN816 was administered as a single intravenous (i.v.) infusion over 2 hours.
OTHER	Placebo	Placebo was administered as a single intravenous (i.v.) infusion over 2 hours.

Timeline

• Start date: 2023-03-03
• Primary completion: 2025-03-26
• Completion: 2025-06-23
• First posted: 2022-09-01
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

37 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, Estonia, France, Germany, Hungary, India, Lithuania, Singapore, Spain, Taiwan

Regulatory

• FDA-regulated drug study