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Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
Sponsor: AstraZeneca
Summary
The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). The primary hypothesis to be evaluated is that AZD2373, compared with placebo, will result in a greater reduction in UACR as assessed by the relative change from Baseline in UACR at Week 30.
Official title: Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-03-05
Completion Date
2027-08-30
Last Updated
2025-10-29
Healthy Volunteers
No
Conditions
Interventions
AZD2373-Arm 1
Accessorized Pre-Filled Syringe (Solution for injection)
AZD2373-Arm 2
Accessorized Pre-Filled Syringe (Solution for injection)
Placebo
Accessorized Pre-Filled Syringe (Solution for injection).
APOL1 Genotyping Clinical Trial Assay
The APOL1 Genotyping Clinical Trial Assay, an investigational use only qualitative Polymerase Chain Reaction invitro diagnostic assay, discriminates between the rs73885319 G1(S342G) and rs71785313 G2 genotypes within the APOL1 gene from DNA extracted from whole blood.
Locations (77)
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Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Irondale, Alabama, United States
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Beverly Hills, California, United States
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Gardena, California, United States
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Los Angeles, California, United States
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Valencia, California, United States
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Brandon, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pompano Beach, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Columbus, Georgia, United States
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Duluth, Georgia, United States
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Hinesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Stockbridge, Georgia, United States
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Chicago, Illinois, United States
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Hinsdale, Illinois, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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Bethesda, Maryland, United States
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Potomac, Maryland, United States
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Boston, Massachusetts, United States
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Roseville, Michigan, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Laurelton, New York, United States
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New York, New York, United States
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Cary, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Gastonia, North Carolina, United States
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Greenville, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Anderson, South Carolina, United States
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Columbia, South Carolina, United States
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Orangeburg, South Carolina, United States
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Spartanburg, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Conroe, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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Alexandria, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Birmingham, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom