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Clinical Trial Active — Not Recruiting Phase II NCT05996835

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

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 •…

📅 08 May 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT05996835
Start
2024-01-18
Completion
2026-02-25
ClinicaliQ Trial Snapshot
  • 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.

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What This Trial Is Studying

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

Full Trial Details
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Eligibility criteria, protocol, and results when available
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