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

Part of paid clinical trials in Alabaster, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06824987
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • APOL1-Mediated Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD2373-Arm 1 — COMBINATION_PRODUCT
    Accessorized Pre-Filled Syringe (Solution for injection)
  • AZD2373-Arm 2 — COMBINATION_PRODUCT
    Accessorized Pre-Filled Syringe (Solution for injection)
  • Placebo — COMBINATION_PRODUCT
    Accessorized Pre-Filled Syringe (Solution for injection).
  • APOL1 Genotyping Clinical Trial Assay — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Oct 2025
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo group
    Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
  • Experimental: AZD2373 - Arm 1
    Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
  • Experimental: AZD2373 - Arm 2
    Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.

Primary Outcome Measure

Relative change in Urine Albumin-Creatinine Ratio (UACR) [ Time Frame: From Baseline at Week 30 ]

Central Contacts

Locations (67)

FacilityCityStateZIPSite coordinators
Research SiteAlabasterAlabama35007-
Research SiteBirminghamAlabama35205-
Research SiteIrondaleAlabama35210-
Research SiteBeverly HillsCalifornia90211-
Research SiteGardenaCalifornia90247-
Research SiteLos AngelesCalifornia90095-
Research SiteValenciaCalifornia91355-
Research SiteBrandonFlorida33511-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33173-
Research SiteOrlandoFlorida32808-
Research SitePompano BeachFlorida33060-
Research SiteAtlantaGeorgia30322-
Research SiteAugustaGeorgia30909-
Research SiteAugustaGeorgia30912-
Research SiteColumbusGeorgia31901-
Research SiteColumbusGeorgia31904-
Research SiteDuluthGeorgia30096-
Research SiteHinesvilleGeorgia31313-
Research SiteLawrencevilleGeorgia30046-
Research SiteMaconGeorgia31210-
Research SiteMaconGeorgia31217-
Research SiteMariettaGeorgia30067-
Research SiteSavannahGeorgia31406-
Research SiteStockbridgeGeorgia30281-
Research SiteChicagoIllinois60612-
Research SiteHinsdaleIllinois60521-
Research SiteLafayetteLouisiana70508-
Research SiteNew OrleansLouisiana70112-
Research SiteBethesdaMaryland20889-
Research SitePotomacMaryland20854-
Research SiteBostonMassachusetts02114-
Research SiteRosevilleMichigan48066-
Research SiteMinneapolisMinnesota55455-
Research SiteTupeloMississippi38801-
Research SiteBrooklynNew York11203-
Research SiteBrooklynNew York11221-
Research SiteLaureltonNew York11413-
Research SiteNew YorkNew York10010-
Research SiteCaryNorth Carolina27511-
Research SiteDurhamNorth Carolina27705-
Research SiteFayettevilleNorth Carolina28304-
Research SiteGastoniaNorth Carolina28054-
Research SiteGreenvilleNorth Carolina27834-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteKinstonNorth Carolina28501-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCincinnatiOhio45246-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-
Research SiteAndersonSouth Carolina29621-
Research SiteColumbiaSouth Carolina29203-
Research SiteOrangeburgSouth Carolina29118-
Research SiteSpartanburgSouth Carolina29306-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37232-
Research SiteConroeTexas77384-
Research SiteDallasTexas75234-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77054-
Research SiteMesquiteTexas75149-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78212-
Research SiteAlexandriaVirginia22311-
Research SiteNorfolkVirginia23510-
Research SiteRichmondVirginia23298-

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