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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already completed, has any data been published about how TIN816 behaved in the body and whether it appeared safe in patients with sepsis-associated acute kidney injury — and what did those early results show?
2This was a Phase 2 trial focused mostly on how the drug moves through the body, not yet on whether it works — so what would you say is still unknown about TIN816's effectiveness, and are there later-stage trials I should know about?
3Because this trial specifically enrolled patients with acute kidney injury caused by sepsis, how does having impaired kidney function affect how a drug like TIN816 is processed — and why does that matter for understanding the safety signals from this study?
4Given that the trial is now completed, what are the current standard-of-care treatments for sepsis-associated acute kidney injury, and how does TIN816 fit into or differ from those existing options?
5If TIN816 showed promising pharmacokinetic results in this trial, what would the next steps typically look like before it could become available as a treatment, and is there any ongoing research I could potentially be considered for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
7
The Apparent Volume of Distribution (Vz) 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