Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
NCT ID: NCT06824987
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2025-03-05
2027-08-30
Brief Summary
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Detailed Description
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Participants with 300 mg/g or greater UACR and eGFR ≥ 25mL/min/1.73m2 will be recruited into the study. Participants on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant will be excluded.
All participants will remain in the study on treatment until the last participant has completed 30 weeks of treatment. The treatment duration will be up to minimum of 30 weeks of study treatment.
Approximately 96 participants will be randomized to study intervention (approximately 32 participants in each treatment group).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Placebo group
* AZD2373 - Arm 1
* AZD2373 - Arm 2
TREATMENT
QUADRUPLE
The Interactive Response technology / Randomisation and Trial Supply Management (IRT/RTSM) will provide to the investigator(s) or pharmacists the kit identification number to be allocated to the participant at the dispensing visit.
Routines for this will be described in the IRT/RTSM user manual provided to each centre.
Study Groups
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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.
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.
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.
AZD2373-Arm 1
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.
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.
AZD2373-Arm 2
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Participants who have high-risk APOL1 genotype (G1/G1; G1/G2; G2/G2). The screening period can be extended if there are delays related to the shipment, handling, or processing of genotype results.
* A geometric mean UACR ≥ 300 mg/g calculated based on the mean of readings taken from 3 FMV urine samples collected on 3 consecutive days. Since the mean will be assessed for eligibility, any of the 3 readings may fall below 300 mg/g.
* eGFR ≥ 25 mL/min/1.73m2.
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria
* Body Mass Index \> 45 kg/m2.
* SBP \> 180 mmHg/DBP \> 110 mmHg (measured when the participant is considered to be at steady state, and preferably when they have taken their BP medications that same day).
* QTcF \> 470 ms.
* Acute coronary syndrome/Acute myocardial infraction +/- coronary intervention with Percutaneous coronary intervention or Coronary artery bypass grafting within 6 months.
* Transient ischaemic attack/ stroke within 3 months.
* High second to third degree AV block or clinically significant sinus node dysfunction untreated with pacemaker.
* A history of ventricular arrhythmias requiring treatment.
* Participants with Type 2 diabetes mellitus must be excluded if ANY of the following conditions are present:
1. Current or any past use of insulin
2. Screening Haemoglobin A1c \> 8.0%
3. Receiving more than one oral anti-hyperglycaemic agent (excluding SGLT inhibitors which can be taken in addition to one other oral anti-hyperglycaemic agent).
* Participant on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant.
* History or serologic evidence of autoimmune-mediated glomerular disease including but not limited to: lupus nephritis (positive lupus serology), ANCA associated vasculitis (antineutrophil cytoplasmic antibody), membranous nephropathy (anti-phospholipase A2 receptor antibody or other autoantibody associated with membranous nephropathy), anti-GBM disease (anti-GBM antibody), or IgA nephropathy.
* Another underlying cause of kidney disease that is not associated with APOL1, including but not limited to polycystic kidney disease or, congenital anomalies of the kidney and urinary tract.
* History of a diagnosed coagulopathy, a major unexplained bleeding event, or other high-risk bleeding diathesis.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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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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
Countries
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Central Contacts
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Other Identifiers
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D6800C00005
Identifier Type: -
Identifier Source: org_study_id
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