SERENIA - A study to investigate AZD4144 in participants with sepsis-associated acute kidney injury.

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  1012792

• Contact name

  Adilah Hussain

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research summary

  Background:
  In a healthy person, the kidneys filter and clean out the blood by removing waste and making urine. Sepsis is a life-threatening complication of an infection in which the body’s natural defence system attacks healthy tissues. For many people, sepsis causes acute kidney injury where the kidneys suddenly stop working properly.
  The trial drug AZD4144 is designed to reduce the inflammation caused by sepsis that leads to acute kidney injury. Researchers believe that in addition to the standard treatment, AZD4144 could help the participants’ kidneys to start working properly again and minimize long-term damage.

  Design:
  This is a Phase 2a, randomized, double-blind, placebo-controlled trial.
  • Randomized means participants will be randomly assigned to a treatment group.
  • Double-blind means none of the participants, researchers, or trial doctors will know what treatment each participant receives.
  • Placebo-controlled means that some participants will receive a placebo. The placebo looks like AZD4144 but does not have any AZD4144 in it.
  
  Population:
  This trial will include about 124 participants. To join this trial, people must be 18 to 80 years old and have acute kidney injury caused by sepsis. Participants must be receiving care in the ICU. Participants must have been diagnosed with sepsis within 7 days of arriving at the hospital and then diagnosed with acute kidney injury within 3 days after being diagnosed with sepsis.
  
  Treatments and Procedures:
  AZD4144 and the placebo are given through a needle directly into a vein over a period of time, also called an IV infusion. Participation will last up to 30 days.

  During the trial, the doctors will perform:
  • Blood and urine tests
  • Physical exams
  • Vital signs checks, including their blood pressure and heart rate
  • Heart function tests using an electrocardiogram (ECG)
  • Medications and treatments questions
  • Report any medical problems

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  25/NW/0240

• Date of REC Opinion

  17 Oct 2025

• REC opinion

  Further Information Favourable Opinion