A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants With Sepsis-associated Acute Kidney Injury (SERENIA)

Summary

This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.

Description

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  AZD4144

  Intravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.

• Drug
  Placebo

  Intravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.

Locations (71)