Recruiting PHASE2 Sepsis

Tests treatment safety and results for Sepsis

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

ClinicalTrials.gov ID: NCT07215702

What this study is testing

What is AZD4144?

AZD4144 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sepsis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

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...
Haemodynamic therapy:
A. 30 mL/kg or clinically appropriate volume resuscitation prior to randomisation.

You likely can't join if

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...
AKI attributed to causes other than sepsis, including but not limited to compromised renal perfusion-related causes (surgical complication, acute...
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%...

See the full eligibility criteria

Who can join

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...
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...
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...
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...
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...

What rules you out

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)...
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...
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...
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...
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...
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...
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...
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...
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.

The study team makes the final eligibility decision.

Where it's taking place

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

+ 46 more site(s).

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tucson, Arizona, United States; Newport Beach, California, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States and 60 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.