ClinicaliQ Trial Snapshot
- Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease — Recruiting • Phase II • NCT06824987.
- What is being tested: AZD2373, a novel therapeutic agent, is undergoing dose-ranging evaluation for safety, tolerability, and efficacy specifically in APOL1-mediated kidney disease, targeting patients with homozygous or compound heterozygous high-risk APOL1 genotypes (G1/G2).
- Patient eligibility overview: The trial enrolls participants with confirmed APOL1-mediated kidney disease who carry high-risk APOL1 genetic variants in homozygous or compound heterozygous patterns, representing a genetically-defined patient population predominantly affecting people of African ancestry.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.