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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: APOL1-Mediated Kidney Disease

In brief

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 facts

Study ID

NCT06824987

Run by

AstraZeneca

People needed

136

Starts

2025-03-05

Expected to finish

2027-08-30

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Current or past use of insulin for more than 3 months and/or any maintenance therapy with insulin within 2 months of screening.
• Screening Haemoglobin A1c > 8.0%
• 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.

Where it is running

• Research Site — Alabaster, Alabama, United States (enrolling)
• Research Site — Irondale, Alabama, United States (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — Beverly Hills, California, United States (enrolling)
• Research Site — Concord, California, United States (enrolling)
• Research Site — Fremont, California, United States (enrolling)
• Research Site — Gardena, California, United States (enrolling)
• Research Site — Surprise, Arizona, United States (enrolling)
• Research Site — Valencia, California, United States (enrolling)
• Research Site — Boca Raton, Florida, United States (enrolling)
• Research Site — Brandon, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Orlando, Florida, United States (enrolling)
• Research Site — Pompano Beach, Florida, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Augusta, Georgia, United States (enrolling)
• Research Site — Augusta, Georgia, United States (enrolling)
• Research Site — Augusta, Georgia, United States (enrolling)
• Research Site — Columbus, Georgia, United States (enrolling)
• Research Site — Columbus, Georgia, United States (enrolling)
• Research Site — Duluth, Georgia, United States (enrolling)
• Research Site — Hinesville, Georgia, United States (enrolling)
• Research Site — Lawrenceville, Georgia, United States (enrolling)
• Research Site — Macon, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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