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Clinical Trials in the UK / NCT06824987
Recruiting Phase 2

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

NCT06824987 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2025-03-05
Last updated
2026-06-25

Condition(s) studied

APOL1-Mediated Kidney Disease

Investigational drug(s) / intervention(s)

AZD2373-Arm 1AZD2373-Arm 2PlaceboAPOL1 Genotyping Clinical Trial Assay

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Research Site Alabaster Alabama Recruiting
Research Site Birmingham Alabama Recruiting
Research Site Irondale Alabama Recruiting
Research Site Surprise Arizona Recruiting
Research Site Beverly Hills California Recruiting
Research Site Concord California Recruiting
Research Site Fremont California Recruiting
Research Site Gardena California Recruiting
Research Site Los Angeles California Not Yet Recruiting
Research Site Valencia California Recruiting
Research Site Boca Raton Florida Recruiting
Research Site Brandon Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Orlando Florida Recruiting
Research Site Pompano Beach Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Augusta Georgia Recruiting
Research Site Augusta Georgia Recruiting
Research Site Augusta Georgia Recruiting
Research Site Columbus Georgia Recruiting
Research Site Columbus Georgia Recruiting
Research Site Duluth Georgia Recruiting
Research Site Hinesville Georgia Recruiting
Research Site Lawrenceville Georgia Recruiting
Research Site Macon Georgia Recruiting
Research Site Macon Georgia Recruiting
Research Site Marietta Georgia Recruiting
Research Site Savannah Georgia Recruiting
Research Site Stockbridge Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Hinsdale Illinois Recruiting
Research Site Rockford Illinois Recruiting
Research Site Baton Rouge Louisiana Recruiting
Research Site Lafayette Louisiana Recruiting
Research Site New Orleans Louisiana Recruiting
Research Site Shreveport Louisiana Recruiting
Research Site Bethesda Maryland Recruiting
Research Site Potomac Maryland Recruiting
Research Site Boston Massachusetts Recruiting

+ 49 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06824987 on ClinicalTrials.gov ↗ ← All trials in the UK