- Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI) — Active Not Recruiting • Phase II • Infectious Disease • NCT05996835.
- TIN816 drug tested at three doses in critically ill patients with kidney injury from sepsis to assess safety and effectiveness.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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). Conditions: Acute Kidney Injury Due to Sepsis Interventions: TIN816 70 mg lyophilisate powder, Placebo Lead Sponsor: Novartis Pharmaceuticals Planned Enrollment: 320 participants