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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Accessorized Pre-Filled Syringe (Solution for injection)
Accessorized Pre-Filled Syringe (Solution for injection)
Accessorized Pre-Filled Syringe (Solution for injection).
Relative change in Urine Albumin-Creatinine Ratio (UACR)
To assess the effect of AZD2373 versus placebo in reducing albuminuria
Time frame: From Baseline at Week 30
Relative change in Urine Albumin-Creatinine Ratio (UACR)
To assess the effect of AZD2373 versus placebo in reducing albuminuria
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in Urine Protein-Creatinine Ratio (UPCR)
To assess the effect of AZD2373 versus placebo in reducing proteinuria
Time frame: From Baseline at Week 30
Relative change in Urine Protein-Creatinine Ratio (UPCR)
To assess the effect of AZD2373 versus placebo in reducing proteinuria
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
Time frame: From Baseline at Week 30
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in eGFR
AstraZeneca Clinical Study Information Center
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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.
Research Site
Alabaster, Alabama, United States
RECRUITINGResearch Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Irondale, Alabama, United States
RECRUITINGResearch Site
Beverly Hills, California, United States
RECRUITINGResearch Site
Gardena, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
NOT_YET_RECRUITINGResearch Site
Valencia, California, United States
RECRUITINGResearch Site
Brandon, Florida, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITING...and 67 more locations
To assess pooled AZD2373 doses versus placebo on eGFR change
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Incidence of development of ADA and ADA titer (if participants are ADA-positive)
To evaluate the immunogenicity of AZD2373
Time frame: During treatment (up to Week 30) and follow-up (up to 12 weeks)
Plasma concentration
To evaluate the PK of AZD2373
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Adverse Events (AEs), Serious Adverse Events (SAEs), and Drug Adverse Events (DAEs).
To assess the safety and tolerability of ranging doses of AZD2373. These events will be collected according to the timepoints specified in the schedule of assessments, starting from the time of signing the Informed Consent Form (ICF).
Time frame: From baseline at the End of Treatment (Until the last participant completes Week 30)