NCT06693765CompletedPhase 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 Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 15 Nov 2024
- Start date
- 18 Nov 2024
- Primary completion date
- 23 Apr 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic kidney disease
- NCT number
- NCT06693765
- EU CT number
- 2024-513848-28-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 41
- From 18 Nov 2024 to the primary completion date, 23 Apr 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant immunosuppressive, steroid treatment.
- Use of any of the prohibited medications in the 4 weeks prior to Visit 1 (Cohorts 1, 3, 4, 5).
Other illness
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment) (Cohort 2).
- Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury (Cohorts 1, 4, 5).
- Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product.
Lab values
- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| - Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.