Renal ImpairmentPhase 1NCT06693765
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 Phase 1 study testing AZD4144 in people with Renal Impairment and End-stage Kidney Disease, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, End-stage Kidney Disease, Healthy Participants
- What is being tested?
- AZD4144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Nov 2024to 23 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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.
Read the detailed description
This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male and female participants with severe renal impairment and end-stage kidney disease (ESKD) compared with healthy control participants.
The study will comprise of:
- A Screening Period of 21 days.
- Cohort 1, 2, 4, and 5: a single Treatment Period with an in-clinic period of 7 days.
- Cohort 3: two Treatment Periods each with an in-clinic period of 7 days, and a washout period of 6 days after the in-clinic treatment period.
- A Follow-up visit 7 days following discharge.
- Being tested
- AZD4144
- Keywords
- Intermittent haemodialysis, Chronic kidney disease, Estimated glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
AZD4144 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AZD4144 | Experimental | Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1. Receives: Drug: AZD4144 |
| Cohort 2: AZD4144 | Experimental | Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1. Receives: Drug: AZD4144 |
| Cohort 3: AZD4144 | Experimental | Participants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2. Receives: Drug: AZD4144 |
| Cohort 4: AZD4144 | Experimental | Participants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1. Receives: Drug: AZD4144 |
| Cohort 5: AZD4144 | Experimental | Participants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1. Receives: Drug: AZD4144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed maximum plasma concentration (Cmax)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Apparent total body clearance (CL/F)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Non-renal clearance of drug from plasma (CLNR/F)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Apparent volume of distribution based on the terminal phase (Vz/F)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Terminal elimination half-life (t½λz)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 14
Renal clearance of drug from plasma (CLR)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 4
Amount excreted (Ae)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 4
Percentage of dose excreted unchanged in urine (fe)
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Measured: From Day 1 to Day 4
Number of Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.
Measured: From Day 1 to Follow-up (Day 14/28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Nov 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693765
- Sponsor's protocol ID
- D9440C00003
- Other IDs
- 2024-513848-28-00
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06693765
- Acronym / sponsor ID
- D9440C00003
- Keywords
- Intermittent haemodialysis, Chronic kidney disease, Estimated glomerular filtration rate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male and female participants with severe renal impairment and end-stage kidney disease (ESKD) compared with healthy control participants.
The study will comprise of:
- A Screening Period of 21 days.
- Cohort 1, 2, 4, and 5: a single Treatment Period with an in-clinic period of 7 days.
- Cohort 3: two Treatment Periods each with an in-clinic period of 7 days, and a washout period of 6 days after the in-clinic treatment period.
- A Follow-up visit 7 days following discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AZD4144 | Experimental | Drug: AZD4144Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 2: AZD4144 | Experimental | Drug: AZD4144Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 3: AZD4144 | Experimental | Drug: AZD4144Participants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2. |
| Cohort 4: AZD4144 | Experimental | Drug: AZD4144Participants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 5: AZD4144 | Experimental | Drug: AZD4144Participants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4144AZD4144 will be administered orally. | Drug | Cohort 1: AZD4144, Cohort 2: AZD4144, Cohort 3: AZD4144, Cohort 4: AZD4144, Cohort 5: AZD4144 |
Primary outcome
Observed maximum plasma concentration (Cmax)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Apparent total body clearance (CL/F)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Non-renal clearance of drug from plasma (CLNR/F)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Terminal elimination half-life (t½λz)
Time frame: From Day 1 to Day 14
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Renal clearance of drug from plasma (CLR)
Time frame: From Day 1 to Day 4
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Amount excreted (Ae)
Time frame: From Day 1 to Day 4
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Percentage of dose excreted unchanged in urine (fe)
Time frame: From Day 1 to Day 4
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 1 to Follow-up (Day 14/28)
To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4144 in people with Renal Impairment and End-stage Kidney Disease, run by AstraZeneca at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed maximum plasma concentration (Cmax) (time frame: From Day 1 to Day 14). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.