Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

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).

Inclusion Criteria: 1. Signed informed consent must be obtained in accordance with local regulations. 2. ≥ 18 to ≤ 85 years of age 3. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU) 4. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: * Suspected or confirmed infection AND * Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the participant is known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection 5. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference serum creatinine. * For participants with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. * For participants presenting from community, the reference serum creatinine should be estimated using the following order of preference: 1. The most recent value within 3 months of the hospital admission. If not available: 2. The most recent value between 3 and 12 months prior to hospital admission. If not available: 3. At hospital admission Exclusion criteria 1. Not expected to survive for 24 hours 2. Not expected to survive for 30 days due to medical conditions other than SA-AKI 3. History of CKD with a documented estimated GFR \