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Study of AZD2373 for APOL1-Mediated Kidney Disease

This study is testing a new treatment called AZD2373 for people with APOL1-Mediated Kidney Disease (AMKD). This kidney disease is linked to specific changes in the APOL1 gene. The study aims to see if AZD2373 is safe and effective in reducing protein in the urine, measured by a test called Urine Albumin-Creatinine Ratio (UACR), compared to a placebo (an inactive substance). You might be able to join if you are 18 to 70 years old, of African descent, and have AMKD with specific APOL1 genetic changes. The study will look for a greater reduction in UACR at Week 30 as a sign of success. The current status of the study is unclear.

Study design
This is a Phase 2b study with 136 participants. It is a blinded study, meaning neither you nor the study staff will know if you are receiving AZD2373 or a placebo.
What's involved
You would receive weekly or every-other-week injections of AZD2373 or placebo. Treatment will last for at least 30 weeks.
Compensation
Not stated in the trial record.
Follow-up
All participants will remain in the study on treatment until the last participant has completed 30 weeks of treatment. You will have the opportunity to enter an Open-Label Extension (OLE) study afterward.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06824987

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
AstraZeneca
~136 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:AZD2373-Arm 1AZD2373-Arm 2PlaceboAPOL1 Genotyping Clinical Trial Assay

At a glance

Recruiting sites
82 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in Urine Albumin-Creatinine Ratio (UACR)
Measured over From Baseline at Week 30

Conditions

APOL1-Mediated Kidney Disease

Explore related trials

APOL1-Mediated Kidney DiseaseAPOL1 Gene

Where it's being run

89 sites across 21 states
Georgia14
United Kingdom10
North Carolina9
Texas7
California6
Florida6
New York5
Louisiana4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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.

What this trial measures

  • Relative change in Urine Albumin-Creatinine Ratio (UACR)From Baseline at Week 30

    To assess the effect of AZD2373 versus placebo in reducing albuminuria