1. Trial Details/Purpose

Chronic Kidney Disease (CKD) affects approximately 37 million adults in the U.S., with 15% of the population at risk. 785,000 people have End-Stage Renal Disease (ESRD), with over 500,000 on dialysis. Diabetes and hypertension are leading causes of CKD, contributing to over 2/3 of kidney failures and it is the 9th leading cause of death, with 50,000 annual deaths.  The Phase 1b clinical trial D9441C00001, sponsored by AstraZeneca, is designed to assess the safety, tolerability, and pharmacodynamics of AZD4144 in participants with established atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD). This randomized, double-blind, placebo-controlled study began on December 16, 2024, and aims to enroll approximately 28 participants across multiple locations, including sites in the United States.​

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​2. Inclusion Criteria

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• Adults aged 18 to 80 years.

• Confirmed diagnosis of ASCVD and CKD.

• Persistent inflammation, indicated by a high-sensitivity C-reactive protein (hsCRP) level greater than 2 mg/L.

• Estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73m².

 

3. Exclusion Criteria

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• History of severe or unstable neuropsychiatric conditions.

• Active severe renal disease not related to CKD.

• Recent history (within the last 24 weeks) of non-SLE diseases requiring prolonged corticosteroid treatment.

• Known primary immunodeficiency, splenectomy, or conditions predisposing to infections.

• Positive tests for HIV, hepatitis B, or hepatitis C.

• History of severe herpes zoster infection or opportunistic infections requiring hospitalization.

• History of cancer, except for certain treated skin or cervical cancers.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location​

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     Northridge