At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
TIN816 70 mg lyophilisate powder +1 morebiological
Likely dose
TIN816 70 mg lyophilisate powderfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Participant and Investigator-blinded, Randomized, Placebo-controlled Phase 2a Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
In Brief
A Phase 2 clinical trial evaluating TIN816 70 mg lyophilisate powder and Placebo for Acute Kidney Injury Due to Sepsis. Completed, enrolled 20 participants across 7 sites in 5 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury Due to Sepsis
CountriesBelgium, France, Germany, Hungary, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartNov 2022
Primary CompletionApr 2024
TodayJul 2026
First PostedAug 19, 2022
Enrollment StartNov 22, 2022
Primary CompletionApr 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.9 years ago
Interventions
TIN816 70 mg lyophilisate powderbiological
Recombinant human CD39 enzyme
Placeboother
0.9% sterile sodium chloride solution