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A study testing how well AZD4144 works and how safe it is for adults with acute kidney injury caused by sepsis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a condition called sepsis-associated acute kidney injury. Sepsis is a serious condition that happens when the body's response to an infection causes damage to its own tissues and organs. Acute kidney injury means that the kidneys suddenly stop working properly and cannot filter waste from the blood as they should. This can happen when a person has sepsis. The study will test a medication called AZD4144, which is given through a vein as a solution for infusion. Some participants will receive AZD4144 while others will receive placebo. The purpose of the study is to evaluate the effect of AZD4144 on how well the kidneys can filter and clean the blood.

Participants in this study will be adults who are in the hospital with sepsis and have developed acute kidney injury. They must have been diagnosed with sepsis within seven days of being admitted to the hospital and must have developed kidney injury within a certain time after the sepsis diagnosis. Participants will need to be receiving medications to support their blood pressure because of the sepsis. The study medication must be given within a specific time window after the kidney injury is diagnosed.

During the study, doctors will measure how well the kidneys are working by checking various blood and urine tests. They will look at substances in the blood called creatinine and cystatin C, which show how well the kidneys are filtering. The study will also track whether participants need kidney replacement therapy, which is a treatment that does the work of the kidneys when they are not working properly. Other measurements will include how many days participants are alive without needing a breathing machine, how long they stay in the intensive care unit, and whether they need to return to the hospital after being discharged. The study will also measure the amount of AZD4144 in the blood to understand how the medication moves through the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    Upon joining the study, you will be randomly assigned to receive either AZD4144 or placebo. A placebo is an inactive substance that looks like the study medication but contains no active ingredient.

    The study medication will be given to you through intravenous infusion, which means it will be delivered directly into your vein through a drip.

    You will receive the first dose of study medication within 36 hours after being diagnosed with sepsis-associated acute kidney injury. Sepsis-associated acute kidney injury is a sudden decrease in kidney function that occurs when you have sepsis, which is a serious condition caused by the body's response to infection.

  2. Step 2

    Monitoring during treatment

    During the treatment period, your kidney function will be monitored through regular measurements of creatinine clearance, which is a test that shows how well your kidneys are filtering waste from your blood.

    Blood samples will be taken to measure serum creatinine and serum cystatin C, which are substances in your blood that help assess kidney function.

    Urine samples will be collected to measure various markers of kidney injury and inflammation.

    Blood samples will also be collected to measure the levels of the study medication in your bloodstream.

    Your overall organ function will be assessed using a scoring system throughout the treatment period.

  3. Step 3

    Observation in intensive care

    Your time in the intensive care unit will be recorded, including the number of days you spend there.

    If you require mechanical ventilation, which is a machine that helps you breathe, the duration of this support will be monitored.

    If you need vasopressor or inotrope therapy, which are medications that help maintain your blood pressure and heart function, the duration of this treatment will be tracked.

    If you require kidney replacement therapy, which is a treatment that performs the work of your kidneys when they are not functioning properly, this will be documented.

  4. Step 4

    Assessment at 30 days

    At 30 days after starting the study, your kidney function will be evaluated by comparing it to your kidney function before the injury occurred.

    The assessment will include whether your kidney function has decreased by 25% or more from your baseline level.

    Any need for kidney replacement therapy during this period will be recorded.

    Your overall health status will be assessed at this time point.

  5. Step 5

    Hospital discharge and follow-up

    The number of days you remain in the hospital will be recorded.

    After you leave the hospital, any readmission to the hospital will be documented.

    The number of days you are alive and not in the hospital will be tracked.

Who can join the trial?

9 criteria

  • You must be between 18 and 80 years old
  • You must be in the hospital with sepsis, which is a serious condition where your body has an extreme response to an infection, diagnosed within 7 days of being admitted
  • You must have acute kidney injury, which means your kidneys have suddenly stopped working as well as they should, diagnosed within 72 hours of your sepsis diagnosis
  • You must be able to receive the study medicine within 36 hours of being diagnosed with kidney injury related to sepsis
  • You or someone legally authorized to make decisions for you must agree to participate in the study
  • Your sepsis diagnosis must be based on having a suspected or confirmed bacterial infection and a sudden worsening in how your organs are working
  • You must have received medicines called vasopressors or inotropes, which help maintain your blood pressure, for at least 4 hours after receiving fluids through your veins
  • Your kidney injury must still be present after you received fluids through your veins
  • Before your kidney injury started, your kidney function must have been at a certain level, either measured before you came to the hospital or when you were first admitted

Who cannot join the trial?

3 criteria

  • The source data does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed information about who cannot join this trial, it is not possible to list the specific conditions or situations that would prevent participation
  • Exclusion criteria typically include things like other medical conditions, certain medications being taken, or specific test results that would make the study unsafe or unsuitable for a patient
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Investigated drugs

  • AZD4144

    is an investigational medication being studied in this trial. It is being tested to see if it can help improve kidney function in patients who have developed acute kidney injury as a result of sepsis, which is a serious condition where the body has an overwhelming response to infection. The study will measure how well this medication works by checking how effectively the kidneys are able to filter waste from the blood.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against AZD4144 to help researchers understand whether any improvements seen are actually due to the medication being tested or would happen naturally over time.

What is already known about the treatment

AZD4144 – AZD4144 is an investigational medication currently being studied in clinical trials for the treatment of acute kidney injury that occurs in patients with sepsis, a serious condition caused by the body's extreme response to infection. The drug is being tested to see if it can improve kidney function by measuring how well the kidneys filter waste products from the blood. This medication is still in the research phase and has not yet been approved for general medical use, as scientists are working to determine its effectiveness, safety, and how well patients tolerate it. The specific way AZD4144 works in the body at the molecular level and its exact form of administration have not been fully disclosed in the available trial information.

Investigated diseases

Sepsis-associated acute kidney injury – This is a condition where the kidneys suddenly lose their ability to filter waste products from the blood due to sepsis, which is a severe infection spreading through the body. The condition develops rapidly, usually within hours to days after the onset of sepsis. The kidneys become damaged because the infection causes widespread inflammation and reduced blood flow to these organs. As the disease progresses, waste products and excess fluids build up in the body because the kidneys cannot perform their normal filtering function. The severity can range from mild kidney dysfunction to complete kidney failure requiring support with medical equipment. This condition is particularly common in patients who are critically ill and being treated in intensive care units.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522232-13-00Protocol codeD9440C00004Estimated enrolment124 patientsSponsorAstraZeneca AB

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