A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
Start Date
2/10/2026
Completion Date
2/11/2027
Summary
This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.
Detailed Description
This is a Phase IIa, randomised, double-blind, placebo-controlled, multicenter study that will be conducted in adult participants (aged 18-80) with sepsis-associated acute kidney injury (SA-AKI). Eligible participants must have sepsis secondary to suspected or confirmed bacterial infection requiring vasopressor or inotrope therapy, and AKI (KDIGO Stage ≥ 1) within a defined time frame of sepsis onset. Participants will be randomised in a 1:1 ratio to receive either intravenous AZD4144 or matching placebo once daily for a fixed treatment period. The study will be comprised of: * A screening period * A treatment period, during which participants receive intravenous AZD4144 or placebo daily according to the protocol dosing days. * A follow-up period that will include daily assessments while still hospitalized and up to two additional outpatient visits at scheduled times after discharge.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
AZD4144
Placebo
Conditions
Locations
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Tucson, Arizona 85719
United States
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Newport Beach, California 92663
United States
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Kansas City, Kansas 66160
United States
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Baltimore, Maryland 21211
United States
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Boston, Massachusetts 02115
United States
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Detroit, Michigan 48202
United States
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The Bronx, New York 10451
United States
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The Bronx, New York 10461
United States
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The Bronx, New York 10467
United States
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Chapel Hill, North Carolina 27519
United States
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Winston-Salem, North Carolina 27157
United States
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Corvallis, Oregon 97330
United States
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Philadelphia, Pennsylvania 19140
United States
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Pittsburgh, Pennsylvania 15213
United States
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Charleston, South Carolina 29402
United States
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Salt Lake City, Utah 84107
United States
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CABA, 1430
Argentina
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Ciudad de Buenos Aires, C1180AAX
Argentina
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La Plata, B1900AVG
Argentina
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Rosario, 2000
Argentina
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Brussels, 1200
Belgium
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Genk, 3600
Belgium
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Jette, 1090
Belgium
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Ottignies, 1340
Belgium
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Lévis, Quebec G6V 3Z1
Canada
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Montreal, Quebec H1T 2M4
Canada
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Montreal, Quebec H2X 3E4
Canada
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Montreal, Quebec H4J 1C5
Canada
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Québec, Quebec G1R 2J6
Canada
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Québec, Quebec G1V 4G5
Canada
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Brno, 656 91
Czechia
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Kolín, 280 02
Czechia
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Prague, 128 08
Czechia
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Prague, 18000
Czechia
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Aarhus N, 8200
Denmark
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Gistrup, 9260
Denmark
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Hvidovre, 2650
Denmark
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Angers, 49033
France
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La Roche-sur-Yon, 85925
France
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Limoges, 87000
France
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Strasbourg, 67091, Cedex
France
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Tours, 37044
France
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Aachen, 52074
Germany
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Essen, 45147
Germany
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Frankfurt, 60590
Germany
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Greifswald, 17475
Germany
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Heidelberg, 69120
Germany
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Kiel, 24105
Germany
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Leipzig, 04103
Germany
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Athens, 11527
Greece
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Thessaloniki, 54642
Greece
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Budapest, 1082
Hungary
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Debrecen, 4032
Hungary
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Kaposvár, 7400
Hungary
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Pécs, 7624
Hungary
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Szeged, 6725
Hungary
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Tatabánya, 2800
Hungary
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Milan, 20122
Italy
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Padua, 35128
Italy
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Roma, 00168
Italy
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Rozzano, 20089
Italy
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Barcelona, 08035
Spain
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Jerez de la Frontera, 11407
Spain
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Valencia, 46026
Spain
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Adapazarı, 54290
Turkey (Türkiye)
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Ankara, 06800
Turkey (Türkiye)
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Kahramanmaraş, 46100
Turkey (Türkiye)
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Kocaeli, 41380
Turkey (Türkiye)
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Brighton, BN2 5BE
United Kingdom
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Guildford, GU27XX
United Kingdom
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Liverpool, L7 8XP
United Kingdom
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London, SE1 7EH
United Kingdom