ClinicaliQ Trial Snapshot
- A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. — Recruiting • Phase II • Infectious Disease • NCT07215702.
- What is being tested: AZD4144, an investigational drug being evaluated for its efficacy, safety, and tolerability in treating sepsis-associated acute kidney injury (AKI), a serious complication combining bacterial infection-induced sepsis with acute kidney dysfunction.
- Patient eligibility overview: Adults aged 18–80 years with confirmed or suspected bacterial sepsis admitted to hospital within 7 days, who have concurrently developed acute kidney injury within 72 hours of admission, forming a high-risk patient cohort requiring urgent intervention.
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What This Trial Is Studying
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…
Eligibility Snapshot
- Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit. 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). Haemodynamic therapy: A. 30 mL/kg or clinically appropriate volume resuscitation prior to randomisation. B. Vasopressor and/or inotrope therapy for sepsis-induced hypotension (eg, norepinephrine [noradrenaline], epinephrine [adrenaline], phenylephrine, dopamine, dobutamine) for ≥ 4 hours. Diagnosis of AKI, within 72 hours of sepsis diagnosis, with modified KDIGO Stage ≥ 1, defined as: Increase in SCr to ≥ 1.5 × baseline (outpatient [preferred] or admission pre-AKI reference). Timing of AKI diagnosis is defined as the time that the initial qualifying SCr was reported. AKI must persist after completion of initial volume resuscitation (30 mL/kg or as clinically indicated per investigator discretion). Outpatient pre-AKI reference eGFR ≥ 30 mL/min/1.73 m2, if available…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.