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 range18 Years – 55 Years

SexALL

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.
✓. Not taking long-term systemic antibiotics with activity against S aureus.

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 completion2026-11-30

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 range18 Years – 55 Years

SexALL

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.
✓. Not taking long-term systemic antibiotics with activity against S aureus.

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