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

NCT06824987 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-10-29

No results posted yet for this 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.

Conditions

  • APOL1-Mediated Kidney Disease

Interventions

COMBINATION_PRODUCT

AZD2373-Arm 1

Accessorized Pre-Filled Syringe (Solution for injection)

COMBINATION_PRODUCT

AZD2373-Arm 2

Accessorized Pre-Filled Syringe (Solution for injection)

COMBINATION_PRODUCT

Placebo

Accessorized Pre-Filled Syringe (Solution for injection).

DEVICE

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2027-08-30
Completion
2027-08-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06824987 on ClinicalTrials.gov