RecruitingPhase 2NCT06824987

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease

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)


Sponsor

AstraZeneca

Enrollment

136 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called APOL1 Genotyping Clinical Trial Assay, AZD2373-Arm 1, and others for people with apol1-mediated kidney disease. The study is currently recruiting participants at 89 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTAZD2373-Arm 1

Accessorized Pre-Filled Syringe (Solution for injection)

COMBINATION_PRODUCTAZD2373-Arm 2

Accessorized Pre-Filled Syringe (Solution for injection)

COMBINATION_PRODUCTPlacebo

Accessorized Pre-Filled Syringe (Solution for injection).

DEVICEAPOL1 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(89)

Research Site

Alabaster, Alabama, United States

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Birmingham, Alabama, United States

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Irondale, Alabama, United States

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Surprise, Arizona, United States

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Beverly Hills, California, United States

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Concord, California, United States

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Fremont, 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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Boca Raton, Florida, 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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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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Rockford, Illinois, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, 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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Lansing, Michigan, 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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Rockville Centre, 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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Butler, Pennsylvania, United States

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Exton, Pennsylvania, 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

View Full Details on ClinicalTrials.gov

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NCT06824987


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