Kidney drug study checks safety in sick and healthy volunteers
NCT ID NCT06693765
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a single dose of the drug AZD4144 in 41 adults with severe kidney disease, end-stage kidney disease, and healthy volunteers. Researchers measured how the drug moves through the body and checked for side effects. The goal was to understand how kidney problems affect the drug's safety and processing, not to treat the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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41 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: 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 other medications that required discontinuation of that medication. * Congenital long QT syndrome. * Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection. * Concomitant immunosuppressive, steroid treatment. * 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). * Use of any of the prohibited medications in the 4 weeks prior to Visit 1 (Cohorts 1, 3, 4, 5). * Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Sofia, 1612, Bulgaria
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Research Site
Bucharest, 010731, Romania
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Other studies related to the condition(s) this trial covers.
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