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

Phase 2b trial testing TIN816 for kidney injury in sepsis.

Recruiting
18-85 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study aims to test a new drug, TIN816, for people with sepsis-associated acute kidney injury, or SA-AKI. *Sepsis* is a severe infection that can lead to organ failure. *Acute kidney injury (AKI)* means the kidneys suddenly can't filter waste from the blood well. The study will test three doses of TIN816 to see how safe and effective it is. Participants must be adults aged 18 to 85, in intensive care, and diagnosed with sepsis and AKI.

Participants will be randomly assigned to receive either the drug or a placebo (a harmless substance) through an IV (a tube that delivers medicine into a vein). The study is *double-blind*, meaning neither the participant nor the researcher knows who gets the actual drug, to ensure fairness. This study involves a screening period (1-2 days), a treatment day (Day 1), and a follow-up period lasting up to 90 days.

  • Participants need to stay in the study for 90 days.
  • Regular hospital visits for observation are required.
  • No monetary compensation is mentioned for participation.
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Study details
    Acute Kidney Injury Due to Sepsis

NCT05996835

Novartis Pharmaceuticals

5 January 2025

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