Clinical trial • Phase II • Infectious Disease|Nephrology

AZD4144 for Sepsis-associated acute kidney injury (AKI)

Phase II trial of AZD4144 for Sepsis-associated acute kidney injury (AKI).

Overview

Trial Therapeutic Area
Infectious Disease|Nephrology
Trial Disease
Sepsis-associated acute kidney injury (AKI)
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-09-2025
First CTIS Authorization Date
14-01-2026

Trial design

Randomised, placebo for azd4144 (placebo arm; product name: "placebo for azd4144"); route noted for investigational product as iv infusion. dose and schedule for comparator not specified in provided data.-controlled Phase II trial in Belgium, Germany, Greece and others.

Randomised
Yes
Comparator
Placebo for AZD4144 (Placebo arm; product name: "Placebo for AZD4144"); route noted for investigational product as IV infusion. Dose and schedule for comparator not specified in provided data.
Target Sample Size
58

Eligibility

Recruits 58 Vulnerable population considerations: critically ill adult ICU patients are included and the protocol acknowledges incapacity scenarios. Informed consent may be provided by the participant or by a legally authorised representative. The submission includes subject information and consent forms for adults, documents for legal representatives (eg, "Legal Representative-Spouse"), materials for adults regaining capacity, information for relatives and participant representative forms, and country/language-specific ICFs, indicating procedures for surrogate consent and for participants who later regain capacity..

Vulnerable Population
Vulnerable population considerations: critically ill adult ICU patients are included and the protocol acknowledges incapacity scenarios. Informed consent may be provided by the participant or by a legally authorised representative. The submission includes subject information and consent forms for adults, documents for legal representatives (eg, "Legal Representative-Spouse"), materials for adults regaining capacity, information for relatives and participant representative forms, and country/language-specific ICFs, indicating procedures for surrogate consent and for participants who later regain capacity.

Inclusion criteria

  • {"criterion_text":"- Adults aged 18 to 80 years"}
  • {"criterion_text":"- Hospitalized with a diagnosis of sepsis (suspected or confirmed) within 7 days of admission"}
  • {"criterion_text":"- Diagnosis of acute kidney injury (AKI; KDIGO Stage ≥ 1) within 72 hours of sepsis diagnosis."}
  • {"criterion_text":"- Able to receive the study drug within 36 hours of SA-AKI diagnosis."}
  • {"criterion_text":"- Provision of informed consent by the participant or legally authorized representative."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Diagnosis of AKI with modified KDIGO Stage ≥ 1 persisting after initial volume resuscitation (30 mL/kg or as clinically indicated per investigator discretion)"}
  • {"criterion_text":"- Outpatient pre-AKI reference eGFR ≥ 30 mL/min/1.73 m2 or admission pre-AKI reference eGFR ≥ 45 mL/min/1.73 m2."}

Exclusion criteria

  • {"criterion_text":"- Known history of Stage 4 or 5 CKD with documented sustained eGFR < 30 mL/min/1.73 m2 prior to hospital admission."}
  • {"criterion_text":"- Known history of cerebrovascular accident within the last 90 days."}
  • {"criterion_text":"- Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis."}
  • {"criterion_text":"- Known hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media."}
  • {"criterion_text":"- Current KRT (eg, continuous haemofiltration and haemodialysis/continuous renal replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT at randomisation."}
  • {"criterion_text":"- Active or planned treatment of sepsis with an extracorporeal haemoperfusion device."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Presence of anuria (≥ 12 hours) at randomisation"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Undergoing extracorporeal membrane oxygenation (ECMO) at randomisation."}
  • {"criterion_text":"- Neutropenia: ANC < 1.5 × 109/L."}
  • {"criterion_text":"- No serum creatinine results available within 12 months of admission and an eGFR < 45 mL/min/1.73 m2 at admission."}
  • {"criterion_text":"- Admitting diagnosis of rhabdomyolysis."}
  • {"criterion_text":"- Admitting diagnosis of trauma with CK > 15000 U/L."}
  • {"criterion_text":"- Presumed nidus of infection in central nervous system."}
  • {"criterion_text":"- First dose of IMP unable to be administered within 36 hours of AKI diagnosis."}
  • {"criterion_text":"- Presence of a do-not-resuscitate order."}
  • {"criterion_text":"- Sepsis diagnosed > 7 days after hospital admission (to include from time of outside admission if patient transferred from another healthcare setting)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Expected survival from sepsis < 24 hours."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl)","definition_or_measurement_approach":"Not specified in provided data"}

Secondary endpoints

  • {"endpoint_text":"- Days alive and free of KRT","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Days alive and free of modified KDIGO AKI Stage 2 or 3","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- AUC: Serum creatinine, Serum cystatin C, mGFR","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Cmax/Cbaseline: Serum creatinine, Serum cystatin C","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- AUC: Plasma and urine IL-18, Plasma and urine IL-6","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Plasma concentrations of AZD4144","definition_or_measurement_approach":"Pharmacokinetic plasma concentration measurements; detailed sampling schedule not specified in provided data"}
  • {"endpoint_text":"- Occurrence of any of the following MAKE30 components: (a) Decrease from pre-AKI reference eGFR of ≥ 25% (b) Initiation of KRT at any time (c) Death from any cause","definition_or_measurement_approach":"Composite MAKE30 definition provided in endpoints; specific adjudication procedures not specified in provided data"}
  • {"endpoint_text":"- Days alive and free of mechanical ventilation","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Days alive and outside of the ICU","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Rehospitalisation","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Days alive and free of hospitalisation","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- Days alive and free of vasopressor and/or inotrope use","definition_or_measurement_approach":"Not specified in provided data"}
  • {"endpoint_text":"- AUC mSOFA score","definition_or_measurement_approach":"Not specified in provided data"}

Recruitment

Planned Sample Size
58
Recruitment Window Months
12
Consent Approach
Informed consent is obtained from the participant or a legally authorised representative (surrogate) if the participant lacks capacity. The submission includes multiple subject information and informed consent forms and addenda (adult ICFs, pregnant participant ICFs, ICFs for legal representatives/spouse, ICFs for adults regaining capacity, information for relatives, participant representative forms). Country/language-specific ICFs are provided (examples in dossier: English, Dutch, French, Greek, Hungarian, Spanish, Danish among others), indicating multilingual consent materials and procedures for surrogate consent and for participants who later regain capacity.

Geography

Total Number Of Sites
38
Total Number Of Participants
66

Belgium

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
52
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Intensive Care
Contact Person Name
Alexis Wérion
Site Name
Ziekenhuis Oost Limburg
Department Name
Intensive Care
Contact Person Name
Tom Fivez
Contact Person Email
tom.fivez@zol.be
Site Name
Clinique Saint-Pierre
Department Name
Intensive Care
Contact Person Name
Nicolas De Schryver
Contact Person Email
nicolas.deschryver@cspo.be
Site Name
UZ Brussel
Department Name
Intensive Care
Contact Person Name
Michaël Mekeirele
Contact Person Email
michael.mekeirele@uzbrussel.be

Germany

Earliest CTIS Part Ii Submission Date
01-12-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
45
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Anästhesiologie und Operative Intensivmedizin
Contact Person Name
Dirk Schädler
Contact Person Email
dirk.schaedler@uksh.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Contact Person Name
Falk Fichtner
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Anästhesiologie
Contact Person Name
Sebastian Decker
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Operative Intensivmedizin und Intermediate Care
Contact Person Name
Tim Philipp Simon
Contact Person Email
tsimon@ukaachen.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik für Anästhesie, Intensiv-, Notfall- und Schmerzmedizin
Contact Person Name
Sven-Olaf Kuhn
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik für Allgemein-, Viszeral-, und Transplantationschirurgie
Contact Person Name
Michael Neuberger
Site Name
Goethe University Frankfurt
Department Name
Klinik fuer Anästhesiologie, Intensivmedizin und Schmerztherapie
Contact Person Name
Kai Zacharowski
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Thorsten Brenner
Contact Person Email
Thorsten.brenner@uk-essen.de

Greece

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
110
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
Adult ICU
Contact Person Name
Eleni Mouloudi
Contact Person Email
elmoulou@yahoo.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Intensive Care Unit, 1st Department of Respiratory Medicine
Contact Person Name
Nikoletta Rovina
Contact Person Email
nikrovina@med.uoa.gr

Hungary

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
48
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Intenzív Terápiás és Aneszteziológiai Osztály
Contact Person Name
Csaba Varga
Contact Person Email
varga.csaba@kmmk.hu
Site Name
University Of Debrecen
Department Name
Anesztezilógiai és Intenzívterápiás Klinika
Contact Person Name
Béla Fülesdi
Contact Person Email
fulesdi@med.unideb.hu
Site Name
University Of Szeged
Department Name
Aneszteziológiai és Intenzív Terápiás Intézet
Contact Person Name
Barna Babik
Contact Person Email
babik.barna@med.u-szeged.hu
Site Name
University Of Pecs
Department Name
Aneszteziológiai és Intenzív Terápiás Intézet
Contact Person Name
Krisztián Jáksó
Contact Person Email
jakso.krisztian@pte.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Aneszteziológiai és Intenzív Terápiás Osztály
Contact Person Name
Zsuzsanna Molnár
Site Name
Semmelweis University
Department Name
Intenzív Terápiás Klinika
Contact Person Name
Zsolt Molnár
Contact Person Email
molnar.zsolt1@semmelweis.hu

Spain

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
52
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
Medicina intensiva
Contact Person Name
Ángel Estella-García
Contact Person Email
litoestella@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medicina intensiva
Contact Person Name
Ricard Ferrer Roca
Contact Person Email
ricard.ferrer@vallhebron.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medicina intensiva
Contact Person Name
María Jesús Broch Porcar
Contact Person Email
ixuscorreu@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
26-11-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
55
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze dell'emergenza, anestesiologiche e della rianimazione
Contact Person Name
Massimo Antonelli
Site Name
Humanitas Mirasole S.p.A.
Department Name
Anaesthesia and Intensive Care
Contact Person Name
Maurizio Cecconi
Contact Person Email
maurizio-cecconi@hunimed.eu
Site Name
Azienda Ospedaliera di Padova
Department Name
Istituto Anestesia e Rianimazione
Contact Person Name
Annalisa Boscolo Bozza
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Anestesia E Terapia Intensiva
Contact Person Name
Giacomo Grasselli
Contact Person Email
giacomo.grasselli@unimi.it

Denmark

Earliest CTIS Part Ii Submission Date
18-12-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
47
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Aalborg University Hospital
Department Name
Infektionsmedicinsk afdeling
Contact Person Name
Henrik Nielsen
Contact Person Email
henrik.nielsen@rn.dk
Site Name
Region Hovedstaden
Department Name
Infektionsmedicinsk afdeling
Contact Person Name
Thomas Lars Benfield

Czechia

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
130
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje
Department Name
Resuscitacni oddeleni a viceoborova JIP
Contact Person Name
Martin Novacek
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Anesteziologicko.resuscitacni klinika
Contact Person Name
Ivan Cundrle
Contact Person Email
ivan.cundrle@fnusa
Site Name
Fakultni Nemocnice Bulovka
Department Name
Anesteziologicko-resuscitacni oddeleni
Contact Person Name
Jan Benes
Contact Person Email
jan.benes@bulovka.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Klinika anesteziologie, resuscitace a intenzivni mediciny
Contact Person Name
Eva Svobodova
Contact Person Email
eva.svobodova@vfn.cz

France

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
119
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Médecine Intensive
Contact Person Name
Anne-Laure Fedou
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Anesthésie et Réanimation chirurgicale
Contact Person Name
Antoine Roquilly
Contact Person Email
antoine.roquilly@chu-nantes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Médecine Intensive - Réanimation
Contact Person Name
Ferhat Meziani
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Unité de Soins intensifs
Contact Person Name
Axel Ponthier
Contact Person Email
axel.ponthieu@ght85.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Médecine Intensive - Réanimation
Contact Person Name
Denis Garot
Contact Person Email
d.garot@chu-tours.fr

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD4144
Active Substance
AZD4144
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
Placebo for AZD4144
Modality
Other

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