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

NCT07215702 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: D9440C000042025-522232-13-0054675
• Study Type: interventional
• Target: 124
• Locations: 14 countries
• Sites: 71

Brief 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.

Conditions

Sepsis; Acute Kidney Injury

Keywords

Sepsis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl).

  The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.

  During the treatment period.

Secondary Outcomes (19)

• Days alive and free of KRT.

  Through study completion, an average of 30 days.

• Days alive and free of modified KDIGO AKI Stage 2 or 3.

  Through study completion, an average of 30 days

• AUC: SCr

  During the treatment period.

• AUC: Serum Cystatin C

  During the treatment period

• AUC: mGFR

  During the treatment period.

Study Arms (2)

Arm 1 (AZD4144)

EXPERIMENTAL

AZD4144 solution for IV infusion

Drug: AZD4144

Arm 2 (Placebo)

PLACEBO COMPARATOR

Placebo concentrate for solution for infusion

Drug: Placebo

Interventions

AZD4144 DRUG

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

Arm 1 (AZD4144)

Placebo DRUG

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

Arm 2 (Placebo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 within 2 weeks to 12 months prior to admission (preferred). If not available, admission pre-AKI reference eGFR ≥ 45 mL/min/1.73 m2 .
• Body weight ≥ 40 kg or ≤ 125 kg. Female or male, assigned at birth, inclusive of all gender identities. All FOCBP must have a negative pregnancy test at the Screening visit (Visit 1).
• Contraception:
• A. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods detailed in CSP from the time of first administration of study intervention administration until 100 days after the last dose of study intervention.
• B. FOCBP must not be lactating and must agree to use an approved method of highly effective contraception, as detailed in the CSP from the time of first administration of study intervention until 100 days after last dose of study intervention.
• Capable of giving signed informed consent (participant or LAR). Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research.

You may not qualify if:

• Known history of Stage 4 or 5 CKD with documented sustained eGFR \< 30 mL/min/1.73 m2 prior to hospital admission.
• Sepsis diagnosed \> 7 days after hospital admission (to include from time of outside admission if patient transferred from another healthcare setting).
• 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.
• Evidence of recovery from AKI prior to randomisation defined as:
• A. A reduction of SCr to less than 1.5 times reference SCr in the last available local SoC laboratory result before randomisation or B. A \> 25% reduction in SCr from peak SCr after volume resuscitation prior to randomisation.
• Expected survival from sepsis \< 24 hours. Expected survival \< 90 days due to chronic or pre-existing medical conditions other than SA-AKI Known history of renal transplant or bilateral nephrectomy. Permanent incapacitation. Incapacitation is defined as the inability to independently perform tasks essential to personal health and/or safety.
• Active cancer or cancer in remission for less than 2 years. Known history of immunodeficiency disease or currently receiving immunosuppressant therapy for non-sepsis related disease.
• Severe burns requiring ICU treatment. Sepsis attributed to confirmed or presumed fungal or viral infection at time of Screening.
• Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C).
• Known history of cerebrovascular accident within the last 90 days. Known history of heart failure with reduced ejection fraction with documented ejection fraction ≤ 20% before sepsis diagnosis.
• Known hypersensitivity to iohexol or known history of severe adverse reaction to iodinated contrast media.
• Participants with known medical or psychological condition(s), or who, in the judgement of the investigator, should not participate in the study if they are unlikely to comply with study procedures, restrictions, and requirements.
• Current KRT (eg, continuous haemofiltration and haemodialysis/continuous kidney replacement therapy, intermittent haemodialysis, and peritoneal dialysis) or planned KRT (meaning KRT is scheduled, or the decision to initiate KRT has been made by the treating physician) at randomisation.
• Currently receiving active treatment for malignancy.
• Potential participants will be excluded if they have received a certain class of medication during the weeks before enrollment or are anticipated to require a specific class of medication during the trial duration.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (71)

Research Site

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

Research Site

Newport Beach, California, 92663, United States

NOT YET RECRUITING

Research Site

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Research Site

Baltimore, Maryland, 21211, United States

NOT YET RECRUITING

Research Site

Boston, Massachusetts, 02115, United States

RECRUITING

Research Site

Detroit, Michigan, 48202, United States

RECRUITING

Research Site

The Bronx, New York, 10451, United States

RECRUITING

Research Site

The Bronx, New York, 10461, United States

NOT YET RECRUITING

Research Site

The Bronx, New York, 10467, United States

NOT YET RECRUITING

Research Site

Chapel Hill, North Carolina, 27519, United States

NOT YET RECRUITING

Research Site

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Research Site

Corvallis, Oregon, 97330, United States

WITHDRAWN

Research Site

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

Research Site

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Research Site

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Research Site

Salt Lake City, Utah, 84107, United States

WITHDRAWN

Research Site

CABA, 1430, Argentina

WITHDRAWN

Research Site

Ciudad de Buenos Aires, C1180AAX, Argentina

NOT YET RECRUITING

Research Site

La Plata, B1900, Argentina

NOT YET RECRUITING

Research Site

Rosario, 2000, Argentina

NOT YET RECRUITING

Research Site

Brussels, 1200, Belgium

RECRUITING

Research Site

Genk, 3600, Belgium

RECRUITING

Research Site

Jette, 1090, Belgium

RECRUITING

Research Site

Ottignies, 1340, Belgium

RECRUITING

Research Site

Lévis, Quebec, G6V 3Z1, Canada

RECRUITING

Research Site

Montreal, Quebec, H1T 2M4, Canada

WITHDRAWN

Research Site

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Research Site

Montreal, Quebec, H4J 1C5, Canada

NOT YET RECRUITING

Research Site

Québec, Quebec, G1R 2J6, Canada

RECRUITING

Research Site

Brno, 656 91, Czechia

NOT YET RECRUITING

Research Site

Kolín, 280 02, Czechia

NOT YET RECRUITING

Research Site

Prague, 128 08, Czechia

WITHDRAWN

Research Site

Prague, 18000, Czechia

RECRUITING

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Aarhus N, 8200, Denmark

WITHDRAWN

Research Site

Gistrup, 9260, Denmark

NOT YET RECRUITING

Research Site

Hvidovre, 2650, Denmark

RECRUITING

Research Site

Angers, 49033, France

WITHDRAWN

Research Site

La Roche-sur-Yon, 85925, France

RECRUITING

Research Site

Limoges, 87000, France

RECRUITING

Research Site

Strasbourg, 67091, Cedex, France

NOT YET RECRUITING

Research Site

Tours, 37044, France

RECRUITING

Research Site

Aachen, 52074, Germany

RECRUITING

Research Site

Essen, 45147, Germany

NOT YET RECRUITING

Research Site

Frankfurt, 60590, Germany

RECRUITING

Research Site

Greifswald, 17475, Germany

RECRUITING

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Heidelberg, 69120, Germany

NOT YET RECRUITING

Research Site

Kiel, 24105, Germany

SUSPENDED

Research Site

Leipzig, 04103, Germany

NOT YET RECRUITING

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Athens, 11527, Greece

RECRUITING

Research Site

Thessaloniki, 54642, Greece

RECRUITING

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Budapest, 1082, Hungary

NOT YET RECRUITING

Research Site

Debrecen, 4032, Hungary

NOT YET RECRUITING

Research Site

Kaposvár, 7400, Hungary

NOT YET RECRUITING

Research Site

Pécs, 7624, Hungary

NOT YET RECRUITING

Research Site

Szeged, 6725, Hungary

NOT YET RECRUITING

Research Site

Tatabánya, 2800, Hungary

NOT YET RECRUITING

Research Site

Milan, 20122, Italy

WITHDRAWN

Research Site

Padua, 35128, Italy

WITHDRAWN

Research Site

Roma, 00168, Italy

WITHDRAWN

Research Site

Rozzano, 20089, Italy

WITHDRAWN

Research Site

Barcelona, 08035, Spain

RECRUITING

Research Site

Jerez de la Frontera, 11407, Spain

RECRUITING

Research Site

Valencia, 46026, Spain

RECRUITING

Research Site

Adapazarı, 54290, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Ankara, 06530, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Kahramanmaraş, 46040, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Kocaeli, 41380, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Brighton, BN2 5BE, United Kingdom

RECRUITING

Research Site

Guildford, GU27XX, United Kingdom

RECRUITING

Research Site

Liverpool, L7 8XP, United Kingdom

RECRUITING

Research Site

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind; Investigators, blinded Sponsor staff, site staff, and participants will remain blinded to each participant's assigned study intervention throughout the course of the study (with the exception of the site pharmacist(s) or designee preparing the IMP and unblinded Monitors/CRAs).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo-controlled, multicentre study.

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): February 11, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (4); CA (5); US (16); AR (4); HU (6); FR (5); DK (3); BE (4); CZ (4); GR (2); IT (4); TU (4); DE (7); ES (3)