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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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)

A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. (NCT07215702) is a Phase 2 interventional studying Sepsis and Acute Kidney Injury, sponsored by AstraZeneca. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Sepsis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 124 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Sepsis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the willing to sign a consent form. 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 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 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 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. Exclusion Criteria Any clinical evidence which in the investigator's opinion makes it undesirable for the potential participant to enrol in the study. 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. Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product. Receipt of another IMP within 30 days, 5 half-lives, or the time frame of expected PD effect from most recent dose, whichever is longest. Previous receipt of AZD4144. Active or planned treatment of sepsis with an extracorporeal haemoperfusion device. Participation in any other concurrent ICU study which could impact participant clinical outcomes and confound results of this study to, including but not limited to volume resuscitation, vasopressor, or mechanical ventilation studies. Presence of anuria (≥ 12 hours) at randomisation. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening, as judged by the investigator. Prolonged QTcF \> 470 ms. Known history of QT prolongation associated with other medications that required discontinuation of that medication. Congenital long QT syndrome. Known history of ST-elevation myocardial infarction or non-ST-elevation myocardial infarction, with or without intervention by percutaneous coronary intervention or coronary artery bypass grafting within the last 90 days. Ventricular arrhythmia requiring treatment. Known or presumed latent or active tuberculosis. Acute pancreatitis with no established source of infection. Undergoing extracorporeal membrane oxygenation (ECMO) at randomisation. Neutropenia: ANC \< 1.5 × 109/L. Admitting diagnosis of rhabdomyolysis. Admitting diagnosis of trauma with CK \> 15000 U/L. Presumed nidus of infection in central nervous system. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous randomisation in the present study. For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. First infusion of IMP unable to be started within 36 hours of AKI diagnosis. Presence of a do-not-resuscitate order.

Treatments Being Tested

DRUG

AZD4144

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

DRUG

Placebo

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Research Site
Tucson, Arizona, United States
Research Site
Newport Beach, California, United States
Research Site
Kansas City, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Corvallis, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Salt Lake City, Utah, United States
Research Site
CABA, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
La Plata, Argentina
Research Site
Rosario, Argentina

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07215702), the sponsor (AstraZeneca), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07215702 clinical trial 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 other assessments. After the Treatment Period, part… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07215702?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07215702?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07215702. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07215702. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.