Phase IIa Study to Evaluate Safety and Effectiveness of AZD4144 in Adults with Sepsis-Related Acute Kidney Injury

What this Trial Is About

Researchers are evaluating AZD4144 in adults aged 18 to 80 years who have sepsis caused by a suspected or confirmed bacterial infection and have developed acute kidney injury within 72 hours of sepsis onset. This Phase IIa study is randomized, double-blind, and placebo-controlled, aiming to assess the efficacy, safety, and tolerability of AZD4144 compared to placebo. The main goal is to compare kidney function measurements between participants receiving AZD4144 and those receiving placebo. Participants will be randomly assigned to receive either intravenous AZD4144 or a matching placebo once daily for a fixed treatment period according to the study protocol. The study includes a screening period, followed by the treatment period during which the study drug or placebo is administered daily. After treatment, participants will be monitored daily while hospitalized and will have up to two outpatient follow-up visits after discharge. During the study, participants will undergo daily safety monitoring, blood and urine sample collection, and various assessments to evaluate kidney function and other health outcomes. Researchers will measure specific kidney function markers such as creatinine clearance and serum cystatin C during treatment, and monitor participants for up to about 30 days for additional health outcomes including kidney replacement therapy use and survival. Safety and tolerability will also be assessed throughout the study period.

A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.