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New drug aims to shield dialysis patients from deadly staph infections

NCT ID NCT06749457

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests a new drug called AZD7760 in healthy volunteers and people with end-stage kidney disease who are on dialysis. The goal is to see if the drug is safe and how the body processes it. If it works, it could help prevent serious staph infections that often occur in dialysis patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD7760 (a drug given as a single intravenous infusion)
What this could lead to
If successful, this could lead to a new way to prevent dangerous staph infections in people on dialysis, reducing hospital stays and complications.
What could go wrong
This is an early-phase trial (Phase I/IIa) focused on safety and dosing, so it is not yet known if AZD7760 actually works. The drug may cause side effects or fail to show benefit in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 231 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Phase I: * Participant must be 18 to 55 years of age (inclusive), at the time of signing the informed consent. * Body weight ≥ 45 kilograms (kg) and ≤ 110 kg and Body Mass Index (BMI) within the range ≥ 18.0 to ≤ 30.0 kilograms per square meter (kg/m2) (inclusive) at screening. * Healthy participants with no clinically significant concomitant diseases or medications (except for those specifically permitted by the protocol) according to medical history, physical examination, screening safety laboratory tests, and screening parameters, as per the judgement of the investigator. Phase IIa: * Participant must be ≥ 18 years of age at the time of signing the informed consent. * Participants who meet all of the following disease status requirements: 1. Diagnosed with End-stage kidney disease (ESKD). 2. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis. 3. Receiving hemodialysis for treatment of ESKD for at least 60 days before randomization. 4. At least 3 previous dialysis sessions using current dialyzer. 5. Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days. 6. No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study. 7. Not taking long-term systemic antibiotics with activity against S aureus. Exclusion Criteria: Phase I: * Known hypersensitivity to any component of the study intervention * Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs). * Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. * Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upper limit of normal (ULN) at screening. Testing may be repeated once at the investigator's discretion. * Estimated glomerular filtration rate \< 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at screening. * Hemoglobin or platelet count below the lower limit of normal at screening. Testing may be repeated once at the investigator's discretion. * White blood cell counts outside normal reference ranges unless judged by the investigator to be out of range given the known variation in white blood cell count reference interval by ethnicity. Testing may be repeated once at the investigator's discretion. * History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years. * Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion. * Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, as judged by the investigator. * Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 28-day Screening Period or may be rescreened once. * Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. * Any condition that has the potential to increase clearance of the study intervention (eg, protein loss conditions such as severe enteropathies, or plasmapheresis). * Blood drawn in excess of a total of 450 milliliters (mL) (1 unit) for any reason within 2 months prior to screening. * Absence of suitable veins for blood sampling and administration of study intervention. * Any other condition that would compromise safety of the participants. * Any condition that, in the opinion of the investigator, might interfere with evaluation of the study intervention or interpretation of participant safety or study results. Phase IIa: * Known hypersensitivity to any component of the study intervention. * History of allergic disease or reactions likely to be exacerbated by any component of the study intervention as listed in dose formulation section. * Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs. * Hemoglobin \< 9 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion. * Serum albumin of \< 3 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion. * Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 90 days prior to randomization. * Known S aureus infection within 90 days of study entry. * Known acute viral or bacterial infection or symptoms/signs consistent with such an infection within the 21 days prior to infusion or study intervention. Mild intercurrent viral illness with a temperature of 38.1 °C (100.6 °F) or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the mAb. * Participants with malignancy undergoing chemotherapy. * Scheduled date for living donor kidney transplant. * Plans to switch to peritoneal dialysis within the primary endpoint time period (181 days). * Regarding arteriovenous fistula (AVF) or arteriovenous graft (AVG): (a) Future AVG or AVG: (i) Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG use within 90 days of randomization are not eligible. (ii) Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG placement, but no plans for AVF or AVG use within 90 days of randomization are eligible. (b) Existing AVG or AVG: (i) Participants with central venous catheters in use for dialysis, but also with an existing AVF or AVG that is not in use and with no future plans for use are eligible.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure Sepsis staphylococcal infection staphylococcus aureus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Staphylococcus aureus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Huntsville, Alabama, 35805, United States

  • Research Site

    WITHDRAWN

    Chula Vista, California, 91910, United States

  • Research Site

    RECRUITING

    Chula Vista, California, 91910, United States

  • Research Site

    RECRUITING

    Glendale, California, 91206, United States

  • Research Site

    RECRUITING

    Granada Hills, California, 91344, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90027, United States

  • Research Site

    RECRUITING

    Northridge, California, 91324, United States

  • Research Site

    RECRUITING

    Northridge, California, 91325, United States

  • Research Site

    RECRUITING

    Oxnard, California, 93036, United States

  • Research Site

    RECRUITING

    Riverside, California, 92503, United States

  • Research Site

    RECRUITING

    San Dimas, California, 91773, United States

  • Research Site

    RECRUITING

    Tarzana, California, 91356, United States

  • Research Site

    RECRUITING

    Valencia, California, 91355, United States

  • Research Site

    RECRUITING

    Victorville, California, 92392, United States

  • Research Site

    RECRUITING

    Englewood, Colorado, 80110, United States

  • Research Site

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Research Site

    RECRUITING

    Coral Springs, Florida, 33071, United States

  • Research Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Research Site

    RECRUITING

    Orlando, Florida, 32806, United States

  • Research Site

    RECRUITING

    Tampa, Florida, 33603, United States

  • Research Site

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60643, United States

  • Research Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Research Site

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21225, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Research Site

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Research Site

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Research Site

    RECRUITING

    Lincoln, Nebraska, 68510, United States

  • Research Site

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Research Site

    RECRUITING

    Jersey City, New Jersey, 07305, United States

  • Research Site

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Research Site

    RECRUITING

    Ridgewood, New York, 11385, United States

  • Research Site

    WITHDRAWN

    Kinston, North Carolina, 28504, United States

  • Research Site

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    RECRUITING

    Bethlehem, Pennsylvania, 18017, United States

  • Research Site

    WITHDRAWN

    Knoxville, Tennessee, 37923, United States

  • Research Site

    RECRUITING

    Beaumont, Texas, 77706, United States

  • Research Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77074, United States

  • Research Site

    RECRUITING

    McAllen, Texas, 78503, United States

  • Research Site

    WITHDRAWN

    San Antonio, Texas, 78215, United States

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