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)
AstraZeneca
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.
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: Male and female participants aged 18 to 65 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 u…
Interventions
- Combination ProductAZD2373-Arm 1
Accessorized Pre-Filled Syringe (Solution for injection)
- Combination ProductAZD2373-Arm 2
Accessorized Pre-Filled Syringe (Solution for injection)
- Combination ProductPlacebo
Accessorized Pre-Filled Syringe (Solution for injection).
- DeviceAPOL1 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.
Locations (77)
- Research SiteAlabaster, Alabama
- Research SiteBirmingham, Alabama
- Research SiteIrondale, Alabama
- Research SiteBeverly Hills, California
- Research SiteGardena, California
- Research SiteLos Angeles, California