COMPLETED

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

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Conditions

Chronic Kidney DiseaseAtherosclerotic Cardiovascular DiseaseCardiorenal diseaseEstimated glomerular filtration rateNucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (NLRP3) cryopyrininflammatory cytokines

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-12-09
Study Completion:2025-10-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06675175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with established ASCVD history of one or more of the following
  2. 1. Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
  3. 2. Prior ischemic stroke (\>60 days from index event)
  4. 3. Symptomatic Peripheral Arterial Disease
  5. * Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to \< 60 mL/min/1.73 m2
  6. * Serum hsCRP \> 2 mg/L
  7. * Body mass index ≥ 18 to ≤ 45 kg/m2
  8. * All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
  9. 1. Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
  10. 2. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
  11. 3. Females of non-childbearing potential must be confirmed at the Screening visit
  1. * History of malignancy within the last 5 years
  2. * History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
  3. * Active systemic infection within 30 days
  4. * Clinically significant active and chronic infections within 60 days prior to randomization
  5. * Clinically significant recurrent infection (≥ 2× during the last 12-month period).
  6. * Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month

Contacts and Locations

Study Locations (Sites)

Research Site
Glendale, California, 91203
United States
Research Site
Daytona Beach, Florida, 32117
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Miami, Florida, 33125
United States
Research Site
Port Orange, Florida, 32127
United States
Research Site
Tampa, Florida, 33603
United States
Research Site
Farmington Hills, Michigan, 48334
United States
Research Site
The Bronx, New York, 10455
United States
Research Site
Sherman, Texas, 75092
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09
Study Completion Date2025-10-27

Study Record Updates

Study Start Date2024-12-09
Study Completion Date2025-10-27

Terms related to this study

Keywords Provided by Researchers

  • Cardiorenal disease
  • Estimated glomerular filtration rate
  • Nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (NLRP3) cryopyrin
  • inflammatory cytokines

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • Atherosclerotic Cardiovascular Disease