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01
Overview
Phase 2, randomised, double-blind trial in acute kidney injury (AKI) comparing TIN816 with Placebo (2 arms). Primary endpoints: Maximum Serum Concentration of TIN816 at Day 90, Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time at Day 90 and 5 more. Started Nov 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
TIN816
TIN816 70 mg administered as single IV dose (n=15)
Placebo
0.9% sterile sodium chloride solution administered as single IV dose (n=5)
03
Who it enrols
Adult ICU patients aged 18-85 years with sepsis (SOFA score ≥2 excluding renal component) and AKI stage 1 or greater, weighing 40-125 kg, without severe chronic kidney disease (eGFR ≥45 mL/min prior to AKI), not on or planned for RRT, without immunosuppression, thrombocytopenia, or high bleeding risk
04
Endpoints
Primary
Maximum Serum Concentration of TIN816
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity
Time to Reach Maximum Serum Concentration
Terminal Elimination Half-life
Secondary
Treatment Emergent Adverse Events
Serious Adverse Events
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