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A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
Sponsor: AstraZeneca
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.
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants With Sepsis-associated Acute Kidney Injury (SERENIA)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2026-02-10
Completion Date
2027-02-11
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
AZD4144
Intravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.
Placebo
Intravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.
Locations (71)
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Tucson, Arizona, United States
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Newport Beach, California, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Corvallis, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Salt Lake City, Utah, United States
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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La Plata, Argentina
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Rosario, Argentina
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Brussels, Belgium
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Genk, Belgium
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Jette, Belgium
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Ottignies, Belgium
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Brno, Czechia
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Kolín, Czechia
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Prague, Czechia
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Prague, Czechia
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Aalborg, Denmark
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Aarhus N, Denmark
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Hvidovre, Denmark
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Angers, France
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La Roche-sur-Yon, France
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Limoges, France
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Strasbourg, France
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Tours, France
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Aachen, Germany
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Essen, Germany
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Frankfurt, Germany
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Greifswald, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Athens, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Kaposvár, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Tatabánya, Hungary
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Milan, Italy
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Padua, Italy
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Roma, Italy
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Rozzano, Italy
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Barcelona, Spain
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Jerez de la Frontera, Spain
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Valencia, Spain
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Adapazarı, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Kahramanmaraş, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Brighton, United Kingdom
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Guildford, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom