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RecruitingPHASE2INTERVENTIONAL

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

This study is for adults aged 18 to 80 who are in hospital with a serious infection called sepsis, and whose kidneys have also been damaged. Doctors believe this damage, known as acute kidney injury, is linked to their sepsis. Participants will be randomly given either the new medicine, AZD4144, or a dummy medicine (placebo) through a drip. The main goal is to find out if AZD4144 is safe and helps improve how well the kidneys work compared to the dummy medicine. Participants will be carefully checked throughout their hospital stay and for a short time after they leave.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
124
Start
10 Feb 2026
Estimated completion
11 Feb 2027

What is this study about?

Imagine your body is fighting a really tough infection, like a bad chest infection or a serious bug in your blood. This serious reaction is called sepsis. Sometimes, when your body is working so hard to fight sepsis, other important organs can be affected, like your kidneys. When kidneys suddenly stop working as well as they should, it’s called acute kidney injury.

This study is trying to find a new way to help people whose kidneys have been damaged because of sepsis. We’re testing a new medicine, AZD4144, to see if it can help the kidneys recover. We’ll be comparing it to a 'placebo', which looks exactly like the new medicine but contains no active drug. This helps us understand if any changes are truly due to the medicine or just a natural recovery.

The main aim is to see if AZD4144 is safe to use and if it can improve how well kidneys are working in people with sepsis-related kidney injury. Your safety will be the top priority throughout the study.

Key takeaways

  • This study is for adults with serious infection (sepsis) and kidney damage.
  • It tests a new medicine, AZD4144, against a dummy medicine (placebo).
  • The goal is to see if AZD4144 is safe and helps kidneys recover.
  • You'll be closely monitored with blood and urine tests.
  • Participation involves hospital stay and follow-up visits after discharge.

Who may be eligible?

This study is looking for adults between 18 and 80 years old. You must be in a hospital's critical care unit (like an ICU) because of a serious infection, known as sepsis.

Crucially, your kidneys must have also been affected within three days of your sepsis starting. Doctors will check this based on your blood and urine tests. You’ll also need to be receiving certain medicines (like ‘vasopressors’) to help keep your blood pressure stable due to the sepsis. Your overall kidney health before getting sick will also be considered.

There are also specific medical details your doctors will need to check to make sure participating is safe and suitable for you. For example, your weight needs to be between 40kg and 125kg.

Quick self-check
  • Are you between 18 and 80 years old?
  • Are you in hospital with a serious infection called sepsis?
  • Have your kidneys been affected within three days of your sepsis starting?
  • Are you receiving medicines to support your blood pressure due to sepsis?
  • Are you within the weight range of 40kg to 125kg?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have some checks to make sure the study is right for you. If you qualify, you'll be randomly assigned to receive either the study medicine (AZD4144) or a dummy medicine (placebo). Neither you nor your study doctor will know which you are receiving.

This medicine will be given once a day through a drip while you are in hospital. During this time, the study team will closely monitor your safety daily, take regular blood and urine samples, and carry out other health checks. After you stop receiving the study medicine, you'll continue to be monitored while you're in hospital and for up to two follow-up visits after you’ve gone home. The total time you're involved in the study, including follow-up, will be determined by how long you're in hospital and when your follow-up visits are scheduled.

Potential risks and benefits

Taking part in this study may or may not directly help you, but the information we gather could help future patients with similar conditions. There's always a possibility of side effects with any new medicine, and the study team will carefully monitor you for any. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

  • Research Site
    Tucson, United States· Not yet recruiting
  • Research Site
    Newport Beach, United States· Not yet recruiting
  • Research Site
    Kansas City, United States· Not yet recruiting
  • Research Site
    Baltimore, United States· Not yet recruiting
  • Research Site
    Boston, United States· Recruiting
  • Research Site
    Detroit, United States· Recruiting
  • Research Site
    The Bronx, United States· Recruiting
  • Research Site
    The Bronx, United States· Not yet recruiting
  • Research Site
    The Bronx, United States· Not yet recruiting
  • Research Site
    Chapel Hill, United States· Not yet recruiting
  • Research Site
    Winston-Salem, United States· Recruiting
  • Research Site
    Corvallis, United States· Withdrawn

+59 more sites — see the official record for the full list.

Common questions

What is sepsis?

Sepsis is your body’s extreme reaction to an infection. It can be life-threatening and quickly cause damage to your organs.

What is acute kidney injury?

Acute kidney injury means your kidneys suddenly stop working as well as they should. This can happen with serious illnesses like sepsis.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real thing but has no active drug. It helps doctors see if the new medicine is truly making a difference.

Will I know if I'm getting the study medicine or the placebo?

No, both you and your doctors involved in the study won't know, which helps make the study fair and accurate. This is called 'double-blind'.

What does 'Phase 2' mean for a study?

Phase 2 means this is an earlier stage study where we're looking to see if the medicine is safe and effective in a small group of people, before testing it in many more.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate the Efficacy, Safety, and Tolerabilit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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