NCT07215702

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase IIa, randomised, double-blind, placebo-controlled, multicenter study that will be conducted in adult participants (aged 18-80) with sepsis-associated acute kidney injury (SA-AKI). Eligible participants must have sepsis secondary to suspected or confirmed bacterial infection requiring vasopressor or inotrope therapy, and AKI (KDIGO Stage ≥ 1) within a defined time frame of sepsis onset. Participants will be randomised in a 1:1 ratio to receive either intravenous AZD4144 or matching placebo once daily for a fixed treatment period. The study will be comprised of: * A screening period * A treatment period, during which participants receive intravenous AZD4144 or placebo daily according to the protocol dosing days. * A follow-up period that will include daily assessments while still hospitalized and up to two additional outpatient visits at scheduled times after discharge.

Conditions

• Sepsis
• Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-10
• Primary completion: 2027-02-11
• Completion: 2027-02-11
• First posted: 2025-10-10
• Last updated: 2026-03-06

Locations

71 sites across 14 countries: United States, Argentina, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study