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[Teste de dispositivo que não é aprovado ou liberado pelo FDA dos EUA] (APPRECIATE)

9 de outubro de 2026 atualizado por: AstraZeneca

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a Phase 2b study to assess efficacy and safety of AZD2373 involving 3 study treatment arms in Part A and 2 study treatment arms in Part B 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.

The study will have Part A and Part B. Part A (n = 96) will have a 1:1:1 randomization of participants to subgroups receiving weekly subcutaneous injections of 50 mg AZD2373, 150 mg AZD2373, and placebo. Part B (n = 40) will have a 4:1 randomization of participants to subgroups receiving every other week subcutaneous injections of 150 mg or placebo. Part B will begin after Part A is completely enrolled.

Both Part A and Part B will have same participant criteria and schedules. The SoA and visit schedule will not change for Part B.

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.

All participants will have the opportunity to enter the OLE study.

Tipo de estudo

Intervencional

Inscrição (Real)

63

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Alabaster, Alabama, Estados Unidos, 35007
        • Research Site
      • Birmingham, Alabama, Estados Unidos, 35205
        • Research Site
      • Irondale, Alabama, Estados Unidos, 35210
        • Research Site
    • Arizona
      • Surprise, Arizona, Estados Unidos, 85374
        • Research Site
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Research Site
      • Concord, California, Estados Unidos, 94520
        • Research Site
      • Fremont, California, Estados Unidos, 94538
        • Research Site
      • Gardena, California, Estados Unidos, 90247
        • Research Site
      • Los Angeles, California, Estados Unidos, 90095
        • Research Site
      • Valencia, California, Estados Unidos, 91355
        • Research Site
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33487
        • Research Site
      • Brandon, Florida, Estados Unidos, 33511
        • Research Site
      • Miami, Florida, Estados Unidos, 33126
        • Research Site
      • Miami, Florida, Estados Unidos, 33173
        • Research Site
      • Orlando, Florida, Estados Unidos, 32808
        • Research Site
      • Pompano Beach, Florida, Estados Unidos, 33060
        • Research Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Research Site
      • Augusta, Georgia, Estados Unidos, 30912
        • Research Site
      • Augusta, Georgia, Estados Unidos, 30909
        • Research Site
      • Augusta, Georgia, Estados Unidos, 30904
        • Research Site
      • Columbus, Georgia, Estados Unidos, 31904
        • Research Site
      • Columbus, Georgia, Estados Unidos, 31901
        • Research Site
      • Duluth, Georgia, Estados Unidos, 30096
        • Research Site
      • Hinesville, Georgia, Estados Unidos, 31313
        • Research Site
      • Lawrenceville, Georgia, Estados Unidos, 30046
        • Research Site
      • Macon, Georgia, Estados Unidos, 31217
        • Research Site
      • Macon, Georgia, Estados Unidos, 31210
        • Research Site
      • Marietta, Georgia, Estados Unidos, 30067
        • Research Site
      • Savannah, Georgia, Estados Unidos, 31406
        • Research Site
      • Stockbridge, Georgia, Estados Unidos, 30281
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Research Site
      • Chicago, Illinois, Estados Unidos, 60643
        • Research Site
      • Hinsdale, Illinois, Estados Unidos, 60521
        • Research Site
      • Rockford, Illinois, Estados Unidos, 61107
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Research Site
      • Lafayette, Louisiana, Estados Unidos, 70508
        • Research Site
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Research Site
      • Shreveport, Louisiana, Estados Unidos, 71103
        • Research Site
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20889
        • Research Site
      • Potomac, Maryland, Estados Unidos, 20854
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Research Site
      • Worcester, Massachusetts, Estados Unidos, 01608
        • Research Site
    • Michigan
      • Lansing, Michigan, Estados Unidos, 48911
        • Research Site
      • Roseville, Michigan, Estados Unidos, 48066
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Research Site
    • Mississippi
      • Columbus, Mississippi, Estados Unidos, 39705
        • Research Site
      • Tupelo, Mississippi, Estados Unidos, 38801
        • Research Site
    • New York
      • Brooklyn, New York, Estados Unidos, 11203
        • Research Site
      • Brooklyn, New York, Estados Unidos, 11221
        • Research Site
      • Laurelton, New York, Estados Unidos, 11413
        • Research Site
      • New York, New York, Estados Unidos, 10010
        • Research Site
      • Rockville Centre, New York, Estados Unidos, 11570
        • Research Site
      • The Bronx, New York, Estados Unidos, 10461
        • Research Site
    • North Carolina
      • Cary, North Carolina, Estados Unidos, 27511
        • Research Site
      • Durham, North Carolina, Estados Unidos, 27705
        • Research Site
      • Fayetteville, North Carolina, Estados Unidos, 28304
        • Research Site
      • Gastonia, North Carolina, Estados Unidos, 28054
        • Research Site
      • Greenville, North Carolina, Estados Unidos, 27834
        • Research Site
      • Jacksonville, North Carolina, Estados Unidos, 28546
        • Research Site
      • Kinston, North Carolina, Estados Unidos, 28501
        • Research Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Research Site
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45246
        • Research Site
      • Columbus, Ohio, Estados Unidos, 43210
        • Research Site
    • Pennsylvania
      • Bridgeville, Pennsylvania, Estados Unidos, 15017
        • Research Site
      • Butler, Pennsylvania, Estados Unidos, 16001
        • Research Site
      • Exton, Pennsylvania, Estados Unidos, 19341
        • Research Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Research Site
    • South Carolina
      • Anderson, South Carolina, Estados Unidos, 29621
        • Research Site
      • Columbia, South Carolina, Estados Unidos, 29203
        • Research Site
      • Orangeburg, South Carolina, Estados Unidos, 29118
        • Research Site
      • Spartanburg, South Carolina, Estados Unidos, 29306
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Research Site
      • Nashville, Tennessee, Estados Unidos, 37232
        • Research Site
    • Texas
      • Conroe, Texas, Estados Unidos, 77304
        • Research Site
      • Conroe, Texas, Estados Unidos, 77384
        • Research Site
      • Dallas, Texas, Estados Unidos, 75234
        • Research Site
      • Dallas, Texas, Estados Unidos, 75235
        • Research Site
      • Houston, Texas, Estados Unidos, 77054
        • Research Site
      • Katy, Texas, Estados Unidos, 77450
        • Research Site
      • Mesquite, Texas, Estados Unidos, 75149
        • Research Site
      • Pearland, Texas, Estados Unidos, 77584
        • Research Site
      • San Antonio, Texas, Estados Unidos, 78212
        • Research Site
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23510
        • Research Site
      • Portsmouth, Virginia, Estados Unidos, 23708
        • Research Site
      • Richmond, Virginia, Estados Unidos, 23298
        • Research Site
  • Reino Unido
      • Birmingham, Reino Unido, B15 2WB
        • Research Site
      • Leicester, Reino Unido, Le5 4PW
        • Research Site
      • Liverpool, Reino Unido, L22 0LG
        • Research Site
      • London, Reino Unido, SE1 9RT
        • Research Site
      • London, Reino Unido, NW3 2QG
        • Research Site
      • London, Reino Unido, SW17 0QT
        • Research Site
      • London, Reino Unido, SE5 8AZ
        • Research Site
      • London, Reino Unido, SM5 1AA
        • Research Site
      • London, Reino Unido, SW7 2AZ
        • Research Site
      • Manchester, Reino Unido, M13 9WL
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants with diagnosis of Type 1 diabetes mellitus.

  • Body Mass Index > 45 kg/m2.

  • SBP > 180 mmHg/DBP > 110 mmHg (measured when the participant is considered to be at steady state, and preferably when they have taken their BP medications that same day).

  • QTcF > 470 ms, except participants with bundle branch block who should excluded if QTcF> 480 ms.

  • Acute coronary syndrome/Acute myocardial infraction with or without any coronary intervention within 6 months.

  • Transient ischaemic attack/ stroke within 3 months.

  • High grade (second to third) degree AV block or clinically significant sinus node dysfunction untreated with pacemaker.

  • A history of ventricular arrhythmias requiring treatment.

  • Participants with Type 2 diabetes mellitus must be excluded if ANY of the following conditions are present:

    1. Current or past use of insulin for more than 3 months and/or any maintenance therapy with insulin within 2 months of screening.
    2. Screening Haemoglobin A1c > 8.0%
    3. Receiving more than one anti-hyperglycaemic agent (excluding SGLT inhibitors and GLP-1 receptor agonists is permitted if prescribed for a purpose other than glycaemic control which can be taken in addition to one other anti-hyperglycaemic agent).

  • Participant on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant.

  • History or serologic evidence of autoimmune-mediated glomerular disease including but not limited to: lupus nephritis (positive lupus serology), ANCA associated vasculitis (antineutrophil cytoplasmic antibody), membranous nephropathy (anti-phospholipase A2 receptor antibody or other autoantibody associated with membranous nephropathy), anti-GBM disease (anti-GBM antibody), or IgA nephropathy.

  • Another underlying cause of kidney disease that is not associated with APOL1, including but not limited to polycystic kidney disease or, congenital anomalies of the kidney and urinary tract.

  • History of a diagnosed coagulopathy, a major unexplained bleeding event, or other high-risk bleeding diathesis.

  • A history of trypanosomiasis or leishmaniasis.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Part A - Placebo group

Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
Produto combinado: Placebo

Accessorized Pre-Filled Syringe (Solution for injection).

Dispositivo: 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.
Experimental: Part A - AZD2373 - Arm 1

Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
Dispositivo: 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.

Produto combinado: AZD2373-Arm 1

Accessorized Pre-Filled Syringe (Solution for injection)
Experimental: Part A - AZD2373 - Arm 2

Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose.
Dispositivo: 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.

Produto combinado: AZD2373-Arm 2

Accessorized Pre-Filled Syringe (Solution for injection)
Experimental: Part B - AZD2373 Arm 1

Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose
Dispositivo: 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.

Produto combinado: AZD2373-Arm 2

Accessorized Pre-Filled Syringe (Solution for injection)
Comparador de Placebo: Part B - Placebo group

Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose
Produto combinado: Placebo

Accessorized Pre-Filled Syringe (Solution for injection).

Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Relative change in Urine Albumin-Creatinine Ratio (UACR)
Prazo: From Baseline at Week 30

To assess the effect of AZD2373 versus placebo in reducing albuminuria
From Baseline at Week 30

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Relative change in Urine Albumin-Creatinine Ratio (UACR)
Prazo: From Baseline at the End of Treatment (Until the last participant completes Week 30)

To assess the effect of AZD2373 versus placebo in reducing albuminuria
From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in Urine Protein-Creatinine Ratio (UPCR)
Prazo: From Baseline at Week 30

To assess the effect of AZD2373 versus placebo in reducing proteinuria
From Baseline at Week 30
Relative change in Urine Protein-Creatinine Ratio (UPCR)
Prazo: From Baseline at the End of Treatment (Until the last participant completes Week 30)

To assess the effect of AZD2373 versus placebo in reducing proteinuria
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)
Prazo: From Baseline at Week 30

To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
From Baseline at Week 30
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
Prazo: From Baseline at the End of Treatment (Until the last participant completes Week 30)

To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
From Baseline at the End of Treatment (Until the last participant completes Week 30)
eGFR slope
Prazo: From Baseline at the End of Treatment (Until the last participant completes Week 30)

To assess pooled AZD2373 doses versus placebo on eGFR change
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)
Prazo: During treatment (up to Week 30) and follow-up (up to 12 weeks)

To evaluate the immunogenicity of AZD2373
During treatment (up to Week 30) and follow-up (up to 12 weeks)
Plasma concentration
Prazo: From Baseline at the End of Treatment (Until the last participant completes Week 30)

To evaluate the PK of AZD2373
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).
Prazo: From baseline at the End of Treatment (Until the last participant completes Week 30)

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).
From baseline at the End of Treatment (Until the last participant completes Week 30)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de março de 2025

Conclusão Primária (Estimado)

4 de outubro de 2027

Conclusão do estudo (Estimado)

4 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de janeiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de fevereiro de 2025

Primeira postagem (Real)

13 de fevereiro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • D6800C00005

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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