Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (NCT05507437) | Clinical Trial Compass
CompletedPhase 2
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
Belgium, France, Germany20 participantsStarted 2022-11-22
Plain-language summary
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. ≥ 18 and ≤ 85 years of age.
✓. Admitted to ICU or intermediate/HDU.
✓. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
✓. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization :
Exclusion criteria
✕. Not expected to survive for 24 hours.
✕. Not expected to survive for 30 days due to medical conditions other than SA-AKI.
✕. History of CKD with a documented estimated GFR \<45 ml/min prior to development of AKI.
✕. Receiving RRT or a decision has been made to initiate RRT within 24 hours of admission.
✕. Weight is less than 40 kg or more than 125 kg .
✕. Has life support limitations (eg, do not resuscitate, do not dialyze, do not intubate).
✕. AKI diagnosis according to the AKI inclusion criteria for a period longer than 48 hours prior to study drug administration.
✕. Presence of AKI for a period longer than 48 hours prior to study drug administration as suggested by clinical manifestations, e.g., prolonged oliguria or severe renal dysfunction (eg, serum creatinine \> 4 mg/dL) on admission without a history of CKD.
What they're measuring
1
Maximum Serum Concentration (Cmax) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
2
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
3
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
4
Time to Reach Maximum Serum Concentration (Tmax) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
5
Terminal Elimination Half-life (T1/2) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
6
Total Body Clearance (CL) of TIN816
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
7
The Apparent Volume of Distribution (Vz) of TIN816