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AZD4144 for Cardiovascular and Kidney Disease

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m2
Be older than 18 years old
Must not have
History of malignancy within the last 5 years
Active systemic infection within 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 28 (pre-dose), day 1 and day 22±1 (post-dose)

Summary

"This trial aims to assess how safe and tolerable AZD4144 is when taken by mouth by individuals with atherosclerotic cardiovascular disease and chronic kidney disease."

Who is the study for?
This trial is for people with atherosclerotic cardiovascular disease and chronic kidney disease. Specific details about who can join are not provided, but typically participants must meet certain health criteria to ensure their safety.
What is being tested?
The study is testing AZD4144, given orally, against a placebo to see its effects on patients with heart and kidney diseases related to atherosclerosis. It aims to assess how safe the drug is and how it affects the body (pharmacodynamics).
What are the potential side effects?
Since this is an early-phase trial assessing safety and tolerability, specific side effects of AZD4144 aren't listed. However, common side effects in such trials may include nausea, headaches, or reactions at the site of administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is reduced but not severely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer within the last 5 years.
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I have not had a serious infection in the last 30 days.
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I have had a heart attack, stroke, or surgery for heart or artery problems in the last 2 months.
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I have not had any serious infections in the last 2 months.
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I have had significant infections at least twice in the last year.
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I have had a kidney transplant, am on dialysis, or had a serious kidney injury in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28 (pre-dose), day 1 and day 22±1 (post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 28 (pre-dose), day 1 and day 22±1 (post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events
Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels
Secondary study objectives
Maximum plasma drug concentration (Cmax)
Observed lowest concentration before the next dose is administered (Ctrough)
Relative change from baseline to 4 weeks in systemic IL-18 and High-sensitivity C-reactive protein (hsCRP) levels
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD4144Experimental Treatment1 Intervention
Participants will receive oral dose of AZD4144 for 28 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive oral dose of Placebo for 28 days.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,565 Total Patients Enrolled
~19 spots leftby Aug 2025
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