TerminatedPhase 2

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

Stopped: Sponsor Decision

United States, Argentina102 participantsStarted 2023-03-03

Plain-language 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.

Who can participate

Age range45 Years – 100 Years

SexALL

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Inclusion criteria

✓. body temperature between 35.0-37.5 °C
✓. blood pressure (systolic 100-160 mmHg, diastolic \< 100 mmHg)
✓. pulse rate (50-100/min) stable with or without medication(s) as per Investigator assessment.

What they're measuring

Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline

Timeframe: Baseline, Day 1 - Day 6

Trial details

NCT IDNCT05524051

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-26

Results submitted2026-03-13

View on ClinicalTrials.gov More Acute Kidney Injury Following Cardiac Surgery trials