A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants … (NCT06693765) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants
A study to investigate the pharmacokinetics, safety, and tolerability of AZD4144 in participants with severe renal impairment, end-stage kidney disease, and in healthy participants.
Who can participate
Age range
18 Years – 80 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:
Healthy Matched Control Participants Only (Cohort 2):
* Stable renal function (for example, no clinically significant change in an estimated glomerular filtration rate (eGFR) within 3 months or longer prior to study the Screening Visit), as determined by the investigator.
* Have an eGFR of ≥ 90 milliliter/minute/1.73m2 (mL/min/1.73m2) as determined via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula without race.
Renally Impaired Participants Only (Cohorts 1, 4 and 5)
* Participants who have renal impairments.
* Cohort 1 participants with severe renal impairment must have an eGFR ≥ 15 to \< 30 mL/min/1.73m2 not on dialysis. Cohort 1 should have at least 3 participants with eGFR ≤ 20 mL/min/1.73m2.
* Cohort 4 participants with moderate renal impairment must have an eGFR of ≥ 30 to \< 60 mL/min/1.73m2.
* Cohort 5 participants with mild renal impairment must have an eGFR of ≥ 60 to \< 90 mL/min/1.73m2.
Cohort 3
* Participants with ESKD on IHD must have been on stable IHD for at least 3 months prior to Visit 1.
* All renally impaired participants should be on stable standard of care for at least 4 weeks prior to Visit 1.
All cohorts:
* Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18 to ≤ 35 kg/m2, inclusive.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Exclusion Criteria:
* History of QT prolongation associated with oth…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Observed maximum plasma concentration (Cmax)
Timeframe: From Day 1 to Day 14
2
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
Timeframe: From Day 1 to Day 14
3
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
Timeframe: From Day 1 to Day 14
4
Apparent total body clearance (CL/F)
Timeframe: From Day 1 to Day 14
5
Non-renal clearance of drug from plasma (CLNR/F)
Timeframe: From Day 1 to Day 14
6
Apparent volume of distribution based on the terminal phase (Vz/F)