Recruiting

Phase 2

AZD2373Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease

Sponsor:

AstraZeneca

Code:

NCT06824987

Conditions

APOL1-Mediated Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

AZD2373-Arm 1

AZD2373-Arm 2

Placebo

APOL1 Genotyping Clinical Trial Assay

Study Details

Brief 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.

Conditions

APOL1-Mediated Kidney Disease

Study ID

NCT06824987

Start date

Mar 5, 2025

Status verified date

Jun, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age: Male and female participants of African descent (including, but not limited to, Black, Black African, Black Caribbean, African American, Afro-Caribbean, Afro-Latino, West African, Mixed Black backgrounds, or other self-identified African diaspora heritage) aged 18 to 70 years, inclusive at the time of informed consent.
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:

Participants with diagnosis of Type 1 diabetes mellitus.
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, except participants with bundle branch block who should excluded if QTcF> 480 ms.
Acute coronary syndrome/Acute myocardial infraction with or without any coronary intervention within 6 months.
Transient ischaemic attack/ stroke within 3 months.
High grade (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 past use of insulin for more than 3 months and/or any maintenance therapy with insulin within 2 months of screening.
2. Screening Haemoglobin A1c > 8.0%
3. Receiving more than one anti-hyperglycaemic agent (excluding SGLT inhibitors and GLP-1 receptor agonists is permitted if prescribed for a purpose other than glycaemic control which can be taken in addition to one other 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.
A history of trypanosomiasis or leishmaniasis.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Part A - 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: Part A - 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: Part A - 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.

experimental: Part B - AZD2373 Arm 1

Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose

placebo comparator: Part B - Placebo group

Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Alabaster, Alabama, United States, 35007

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Birmingham, Alabama, United States, 35205

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Irondale, Alabama, United States, 35210

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Surprise, Arizona, United States, 85374

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Beverly Hills, California, United States, 90211

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Concord, California, United States, 94520

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Fremont, California, United States, 94538

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Gardena, California, United States, 90247

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Valencia, California, United States, 91355

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Boca Raton, Florida, United States, 33487

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Brandon, Florida, United States, 33511

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Miami, Florida, United States, 33126

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Miami, Florida, United States, 33173

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Orlando, Florida, United States, 32808

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Pompano Beach, Florida, United States, 33060

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Atlanta, Georgia, United States, 30322

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Augusta, Georgia, United States, 30904

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Augusta, Georgia, United States, 30909

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Augusta, Georgia, United States, 30912

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Columbus, Georgia, United States, 31901

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Columbus, Georgia, United States, 31904

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Duluth, Georgia, United States, 30096

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Hinesville, Georgia, United States, 31313

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Lawrenceville, Georgia, United States, 30046

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Macon, Georgia, United States, 31210

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Macon, Georgia, United States, 31217

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Marietta, Georgia, United States, 30067

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Savannah, Georgia, United States, 31406

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Stockbridge, Georgia, United States, 30281

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Chicago, Illinois, United States, 60612

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Hinsdale, Illinois, United States, 60521

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Rockford, Illinois, United States, 61107

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Baton Rouge, Louisiana, United States, 70808

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Lafayette, Louisiana, United States, 70508

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New Orleans, Louisiana, United States, 70112

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Shreveport, Louisiana, United States, 71103

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Bethesda, Maryland, United States, 20889

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Potomac, Maryland, United States, 20854

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Boston, Massachusetts, United States, 02114

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Lansing, Michigan, United States, 48911

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Roseville, Michigan, United States, 48066

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Minneapolis, Minnesota, United States, 55455

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Tupelo, Mississippi, United States, 38801

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Brooklyn, New York, United States, 11203

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Brooklyn, New York, United States, 11221

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Laurelton, New York, United States, 11413

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New York, New York, United States, 10010

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Rockville Centre, New York, United States, 11570

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Cary, North Carolina, United States, 27511

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Durham, North Carolina, United States, 27705

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Fayetteville, North Carolina, United States, 28304

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Gastonia, North Carolina, United States, 28054

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Greenville, North Carolina, United States, 27834

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Jacksonville, North Carolina, United States, 28546

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Kinston, North Carolina, United States, 28501

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Winston-Salem, North Carolina, United States, 27103

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Winston-Salem, North Carolina, United States, 27157

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Cincinnati, Ohio, United States, 45246

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Columbus, Ohio, United States, 43210

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Butler, Pennsylvania, United States, 16001

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Exton, Pennsylvania, United States, 19341

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Philadelphia, Pennsylvania, United States, 19104

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Anderson, South Carolina, United States, 29621

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Columbia, South Carolina, United States, 29203

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Orangeburg, South Carolina, United States, 29118

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Spartanburg, South Carolina, United States, 29306

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Nashville, Tennessee, United States, 37232

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Conroe, Texas, United States, 77384

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Dallas, Texas, United States, 75234

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Dallas, Texas, United States, 75235

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Houston, Texas, United States, 77054

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Mesquite, Texas, United States, 75149

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Pearland, Texas, United States, 77584

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San Antonio, Texas, United States, 78212

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Richmond, Virginia, United States, 23298

More Information

Sponsor

AstraZeneca

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

APOL1-Mediated Kidney Disease
AZD2373

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-06-25.