NCT06824987

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

Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2b study to assess efficacy and safety of AZD2373 involving 3 study treatment arms where participants and study personnel including study investigators are blinded to the assigned treatment. Participants with 300 mg/g or greater UACR and eGFR ≥ 25mL/min/1.73m2 will be recruited into the study. Participants on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant will be excluded. All participants will remain in the study on treatment until the last participant has completed 30 weeks of treatment. The treatment duration will be up to minimum of 30 weeks of study treatment. Approximately 96 participants will be randomized to study intervention (approximately 32 participants in each treatment group).

Conditions

• APOL1-Mediated Kidney Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-05
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2025-02-13
• Last updated: 2025-10-29

Locations

77 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study