RecruitingPhase 1/2

A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)

United States231 participantsStarted 2024-12-30

Plain-language summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosed with End-stage kidney disease (ESKD).
. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.
. Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization.
. At least 3 previous dialysis sessions using current dialyzer.
. Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase I/Phase II trial and AZD7760 is still being tested for basic safety and how the body processes it, what does that early stage mean for what's known — and not yet known — about risks for someone like me?
2The Phase IIa part of this trial specifically enrolls adults with end-stage kidney disease on hemodialysis with a central venous catheter — do I meet those criteria, and is my current kidney and dialysis situation a good or concerning fit for a study at this stage?
3Given that the trial is focused on Staphylococcus aureus, is this being studied as a way to prevent infection, treat an existing one, or protect against catheter-related infections, and how does that match what I'm actually facing right now?
4Are there already approved or standard treatments for my situation with Staph aureus that I should consider before looking at an experimental drug still in early safety testing?
5Because the trial is actively recruiting and collecting safety data as a primary goal, what kinds of adverse events or serious side effects are the researchers watching most closely, and how would any problems be handled if they came up during the study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I: Occurence of adverse events (AEs)

Timeframe: Day 1 to Day 181

Phase I: Occurence of medically-attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Timeframe: Day 1 to Day 361

Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIs

Timeframe: Day 1 to Day 181

Trial details

NCT IDNCT06749457

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-02

Contact for this trial

AstraZeneca Clinical Study Information Center

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

View on ClinicalTrials.gov More Staphylococcus Aureus trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosed with End-stage kidney disease (ESKD).
. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.
. Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization.
. At least 3 previous dialysis sessions using current dialyzer.
. Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days.
. 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.

What they're measuring

Phase I: Occurence of adverse events (AEs)

Timeframe: Day 1 to Day 181

Phase I: Occurence of medically-attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Timeframe: Day 1 to Day 361

Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIs

Timeframe: Day 1 to Day 181