Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney… (NCT05996835) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
United States320 participantsStarted 2024-01-18
Plain-language summary
The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses 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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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 in accordance with local regulations.
✓. ≥ 18 to ≤ 85 years of age
✓. Admitted to ICU or intermediate care unit/ high dependency care unit (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:
✓. The most recent value within 3 months of the hospital admission. If not available:
✓. The most recent value between 3 and 12 months prior to hospital admission. If not available:
✓. At hospital admission
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 \<30 mL/min prior to admission to hospital
✕. eGFR \<45mL/min at admission without any other reference serum eGFR within last 12-months
✕. Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization
What they're measuring
1
Average of area under the time-corrected creatinine clearance curve (AUC1-8)
✕. Weight is less than 40 kg or more than 125 kg.
✕. Limitations to the use of mechanical ventilation, RRT or vasopressors/inotropes (N.B. limitations on Cardiopulmonary resuscitation (CPR)e.g., do-not-resuscitate orders are not an exclusion criterion unless associated with likely poor outcome in next 24 hours)
✕. Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission