BridgeMD
A trial to learn how well AZD4144 works, how safe it is, and how it moves throughout the body over time in adults with acute kidney injury caused by sepsis
EU CTIS ID: 2025-522232-13-00
What this study is testing
To evaluate the effect of AZD4144 on Creatinine Clearance (CrCl)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 to 80 years
- Hospitalized with a diagnosis of sepsis (suspected or confirmed) within 7 days of admission
- Diagnosis of acute kidney injury (AKI; KDIGO Stage ≥ 1) within 72 hours of sepsis diagnosis.
- Able to receive the study drug within 36 hours of SA-AKI diagnosis.
- Provision of informed consent by the participant or legally authorized representative.
- Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: (a) Suspected or confirmed bacterial infection AND (b) Acute increase of mSOFA score of 2 or more excluding renal component (change in score measured to account for participants that may meet mSOFA criteria from pre-existing organ dysfunction before the onset of infection).
You likely can't join if
- Known history of Stage 4 or 5 CKD with documented sustained eGFR < 30 mL/min/1.73 m2 prior to hospital admission.
- Known history of cerebrovascular accident within the last 90 days.
- Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis.
- Known hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media.
- Current KRT (eg, continuous haemofiltration and haemodialysis/continuous renal replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT at randomisation.
- Active or planned treatment of sepsis with an extracorporeal haemoperfusion device.
See the full eligibility criteria
Who can join
- Adults aged 18 to 80 years
- Hospitalized with a diagnosis of sepsis (suspected or confirmed) within 7 days of admission
- Diagnosis of acute kidney injury (AKI; KDIGO Stage ≥ 1) within 72 hours of sepsis diagnosis.
- Able to receive the study drug within 36 hours of SA-AKI diagnosis.
- Provision of informed consent by the participant or legally authorized representative.
- Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: (a) Suspected or confirmed bacterial infection AND (b) Acute increase of mSOFA score of 2 or more excluding renal component (change in score measured to account for participants that may meet mSOFA criteria from pre-existing organ dysfunction before the onset of infection).
- Vasopressor and/or inotrope therapy for sepsis-induced hypotension (norepinephrine [noradrenaline], epinephrine [adrenaline], phenylephrine, dopamine, dobutamine) for ≥ 4 hours after 30 mL/kg or clinically appropriate volume resuscitation prior to randomisation
- Diagnosis of AKI with modified KDIGO Stage ≥ 1 persisting after initial volume resuscitation (30 mL/kg or as clinically indicated per investigator discretion)
- Outpatient pre-AKI reference eGFR ≥ 30 mL/min/1.73 m2 or admission pre-AKI reference eGFR ≥ 45 mL/min/1.73 m2.
What rules you out
- Known history of Stage 4 or 5 CKD with documented sustained eGFR < 30 mL/min/1.73 m2 prior to hospital admission.
- Known history of cerebrovascular accident within the last 90 days.
- Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis.
- Known hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media.
- Current KRT (eg, continuous haemofiltration and haemodialysis/continuous renal replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT at randomisation.
- Active or planned treatment of sepsis with an extracorporeal haemoperfusion device.
- Participation in any other concurrent ICU which could impact participant clinical outcomes and confound results of this study to, including but not limited to volume resuscitation, vasopressor, or mechanical ventilation studies.
- Presence of anuria (≥ 12 hours) at randomisation
- Known history of ST-elevation myocardial infarction or non-ST-elevation myocardial infarction, with or without intervention by percutaneous coronary intervention or coronary artery bypass grafting within the last 90 days.
- Undergoing extracorporeal membrane oxygenation (ECMO) at randomisation.
- Neutropenia: ANC < 1.5 × 109/L.
- No serum creatinine results available within 12 months of admission and an eGFR < 45 mL/min/1.73 m2 at admission.
- Admitting diagnosis of rhabdomyolysis.
- Admitting diagnosis of trauma with CK > 15000 U/L.
- Presumed nidus of infection in central nervous system.
- First dose of IMP unable to be administered within 36 hours of AKI diagnosis.
- Presence of a do-not-resuscitate order.
- Sepsis diagnosed > 7 days after hospital admission (to include from time of outside admission if patient transferred from another healthcare setting).
- AKI attributed to causes other than sepsis, including but not limited to compromised renal perfusion-related causes (surgical complication, acute abdominal aortic aneurysm, dissection, renal artery stenosis, etc), glomerular disease, acute interstitial nephritis, and medication toxicity.
- Evidence of recovery from AKI prior to randomisation defined as: (a) A reduction of serum creatinine to less than 1.5 times reference serum creatinine in the last available local SoC laboratory result before randomisation or (b) A > 25% reduction in serum creatinine from peak serum creatinine after volume resuscitation prior to randomisation.
- Expected survival from sepsis < 24 hours.
- Expected survival < 90 days due to chronic or pre-existing medical conditions other than SA-AKI, including but not limited to cancer, end-stage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 30 days, end-stage lung disease, end-stage neurological disease, and end-stage liver disease.
- Known history of immunodeficiency disease or currently receiving immunosuppressant therapy for non-sepsis related disease, including but not limited to treatment for organ transplant, cancer, or autoimmune disease; current treatment with high-dose steroid therapy (dose equivalent to prednisone/prednisolone 0.5 mg/kg/day) exceeding 2 weeks duration. Steroids administered as management of septic shock are permitted.
- Sepsis attributed to confirmed or presumed fungal or viral infection at time of Screening. Concomitant bacteraemia with a viral infection is NOT exclusionary (for example presumed bacteraemia in a participant with documented influenza).
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Argentina
- Canada
- United Kingdom
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Argentina; Canada; United Kingdom; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.