Chronic Kidney DiseasePhase 1NCT06675175
A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
A Phase 1 study testing AZD4144 in people with Chronic Kidney Disease and Atherosclerotic Cardiovascular Disease, run by AstraZeneca at 15 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Atherosclerotic Cardiovascular Disease
- What is being tested?
- AZD4144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 9 Dec 2024to 27 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with established ASCVD history of one or more of the following
- Prior Myocardial infarction (MI) (>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
- Prior ischemic stroke (>60 days from index event)
- Symptomatic Peripheral Arterial Disease
- Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m2
- Serum hsCRP > 2 mg/L
Show all 11Show fewer
- Body mass index ≥ 18 to ≤ 45 kg/m2
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
- Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
- Females of non-childbearing potential must be confirmed at the Screening visit
Who cannot join
- History of malignancy within the last 5 years
- History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
- Active systemic infection within 30 days
- Clinically significant active and chronic infections within 60 days prior to randomization
- Clinically significant recurrent infection (≥ 2× during the last 12-month period).
- Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States9 sites
Research Site
Daytona Beach, Florida, 32117
Research Site
Farmington Hills, Michigan, 48334
Research Site
Glendale, California, 91203
Research Site
Jacksonville, Florida, 32216
Research Site
Miami, Florida, 33125
Research Site
Port Orange, Florida, 32127
Research Site
Sherman, Texas, 75092
Research Site
Tampa, Florida, 33603
Research Site
The Bronx, New York, 10455
Romania2 sites
Research Site
Bucharest, 11658
Research Site
Cluj-Napoca, 400006
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease
The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).
Read the detailed description
This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein [hsCRP] > 2 mg/L and eGlomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo.
The study will be comprised of:
- A screening period of 28 days
- Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days.
- A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration.
The total duration of the study will be approximately 12 weeks.
- Being tested
- AZD4144, Placebo
- Keywords
- Cardiorenal disease, Estimated glomerular filtration rate, Nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (NLRP3) cryopyrin, inflammatory cytokines
- Medical subject headings
- Renal Insufficiency, Chronic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
PlaceboOther
Placebo will be given orally to randomized participants as per the arm they are assigned.
| Study group | Role | What they receive |
|---|---|---|
| AZD4144 | Experimental | Participants will receive oral dose of AZD4144 for 28 days. Receives: Drug: AZD4144 |
| Placebo | Placebo comparator | Participants will receive oral dose of Placebo for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
Measured: From first dose (Day 1) until Follow-up (Day 56±1)
Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
Measured: Day 1 to Day 28
Secondary outcomes (4)
Relative change from baseline to 4 weeks in systemic IL-18 and High-sensitivity C-reactive protein (hsCRP) levels
The effect of AZD4144 on circulating inflammatory biomarkers IL-18 and hsCRP compared with placebo will be evaluated.
Measured: Day 1 to Day 28
Maximum plasma drug concentration (Cmax)
The Cmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Measured: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Time to reach maximum observed concentration (tmax)
The tmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Measured: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Observed lowest concentration before the next dose is administered (Ctrough)
The Ctrough after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Measured: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start9 Dec 2024
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675175
- Sponsor's protocol ID
- D9441C00001
- Other IDs
- 2024-516840-24-00
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06675175
- Acronym / sponsor ID
- D9441C00001
- Keywords
- Cardiorenal disease, Estimated glomerular filtration rate, Nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (NLRP3) cryopyrin, inflammatory cytokines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 5 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.
The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).
Detailed description
This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein [hsCRP] > 2 mg/L and eGlomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo.
The study will be comprised of:
- A screening period of 28 days
- Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days.
- A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration.
The total duration of the study will be approximately 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD4144 | Experimental | Drug: AZD4144Participants will receive oral dose of AZD4144 for 28 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive oral dose of Placebo for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with established ASCVD history of one or more of the following
- Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m2
- Serum hsCRP > 2 mg/L
- Body mass index ≥ 18 to ≤ 45 kg/m2
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
Key exclusion criteria (6 listed)
- History of malignancy within the last 5 years
- History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
- Active systemic infection within 30 days
- Clinically significant active and chronic infections within 60 days prior to randomization
- Clinically significant recurrent infection (≥ 2× during the last 12-month period).
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 |
|---|---|---|
| AZD4144Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned. | Drug | AZD4144 |
| PlaceboPlacebo will be given orally to randomized participants as per the arm they are assigned. | Other | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: From first dose (Day 1) until Follow-up (Day 56±1)
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels
Time frame: Day 1 to Day 28
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
4 secondary outcomes
Relative change from baseline to 4 weeks in systemic IL-18 and High-sensitivity C-reactive protein (hsCRP) levels
Time frame: Day 1 to Day 28
Maximum plasma drug concentration (Cmax)
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Time to reach maximum observed concentration (tmax)
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
Observed lowest concentration before the next dose is administered (Ctrough)
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
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 25 Nov 2025.
- 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. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
15 sites in 4 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 Chronic Kidney Disease and Atherosclerotic Cardiovascular Disease, run by AstraZeneca at 15 sites in 4 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 11 inclusion and 6 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Bulgaria, Hungary, 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events (time frame: From first dose (Day 1) until Follow-up (Day 56±1)). The study lists 2 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 25 Nov 2025.