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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07215702
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD4144 — DRUG
    Intravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.
  • Placebo — DRUG
    Intravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Apr 2026
Primary completion
Feb 11, 2027
Completion
Feb 11, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (AZD4144)
    AZD4144 solution for IV infusion
  • Placebo Comparator: Arm 2 (Placebo)
    Placebo concentrate for solution for infusion

Primary Outcome Measure

Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl). [ Time Frame: During the treatment period. ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteNewport BeachCalifornia92663-
Research SiteKansas CityKansas66160-
Research SiteBaltimoreMaryland21211-
Research SiteBostonMassachusetts02115-
Research SiteDetroitMichigan48202-
Research SiteThe BronxNew York10451-
Research SiteThe BronxNew York10461-
Research SiteThe BronxNew York10467-
Research SiteChapel HillNorth Carolina27519-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCorvallisOregon97330-
Research SitePhiladelphiaPennsylvania19140-
Research SitePittsburghPennsylvania15213-
Research SiteCharlestonSouth Carolina29425-
Research SiteSalt Lake CityUtah84107-

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