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Carfilzomib e Belatacept para Dessensibilização (ADAPT)

2 de novembro de 2026 atualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

Medindo o Impacto de Carfilzomib e Belatacept na Dessensibilização Alogênica em Possíveis Receptores de Transplante Renal (ITN089ST)

Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die while on the kidney transplant waitlist.

The purpose of this study is to find out whether two drugs, carfilzomib (Kyprolis®),and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study enrolled 21 eligible participants, 18 to 65 years of age, with end stage renal failure on dialysis who are on the waiting list for a deceased donor transplant with calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) or, those with cPRA >98% and an human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program. The study will evaluate whether the study treatment is safe and can lower the participant's immune system's sensitization to kidney donors, making it easier to find a well-matched kidney for them.

Participants in the study were enrolled in two consecutive Cohorts. The total duration of participation in the study will be 76 weeks for Cohort 1 and 68 weeks for Cohort 2. Participants who undergo kidney transplantation while enrolled in the study will have 52 weeks of follow up post-transplant.

The duration of participation for living donors is one study visit. Their participation in the study ends upon completion of this study visit.

Tipo de estudo

Intervencional

Inscrição (Real)

21

Estágio

  • Fase 2
  • Fase 1

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
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke Transplant Center, Duke University Medical Center

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:

Individuals who meet all of the following criteria are eligible for enrollment as study subjects-

  1. Subject must be able to understand and provide informed consent

  2. End stage renal disease (ESRD) on dialysis

  3. United Network for Organ Sharing (UNOS) listed for a kidney transplant with any one of the following:

    • Current calculated panel reactive antibodies (cPRA) ≥ 99.9 percent awaiting deceased donor transplant
    • Current cPRA >98 percent (with >5 years of waiting time) awaiting deceased donor transplant
    • Current cPRA >98 percent with Human Leukocyte Antigen (HLA)-incompatible approved living donor and has not received a transplant after 1 year in a kidney paired exchange program

  4. Evidence of established immunity to Epstein-Barr virus (EBV) as demonstrated by serologic testing

  5. Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy.

    • Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB).

    • Negative results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB.

    • Subjects with a positive test result must have completed appropriate therapy for LTBI.

      • Note: LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC), url: https://www.cdc.gov/tb/topic/treatment/ltbi.htm

  6. Negative Food and Drug Administration (FDA)-approved test for human immunodeficiency virus (HIV) diagnosis (at screening or as documented in medical record, up to 6 months prior to screening)

  7. Negative Hepatitis C antibody test at screening or as documented in medical record, up to 6 months prior to screening.

    --If there is a history of treated hepatitis C then documentation of two consecutive negative HCV quantitative ribonucleic acid (RNA) polymerase chain reaction (PCR) tests separated by at least 6 months is required. Untreated subjects with positive HCV antibody and a single negative HCV quantitative HCV RNA are eligible.

  8. Negative result for SARS-CoV-2 by an FDA-authorized molecular diagnostic test. Examples include, but are not limited to RT-PCR, LAMP, TMA, and qSTAR. Candidates with a history of recent COVID infection may proceed despite a positive result if they have had complete clinical recovery and it has been >/= 21 days since the initial diagnosis.

  9. Subjects must have an echocardiogram within the previous 1 year without any of the following findings:

    • severe left ventricular hypertrophy (LVH)
    • greater than mild LVH accompanied by diastolic dysfunction
    • left ventricular ejection fraction <40 percent
    • pulmonary hypertension defined as right ventricular systolic pressure >35 mm Hg or tricuspid regurgitant velocity >2.8 m/s

  10. Female subjects of reproductive potential must have a negative pregnancy test upon study entry

  11. All subjects of reproductive potential must agree to use contraception for the duration of the study

  12. Subjects must have current vaccinations or documented immunity to:

    • varicella (chickenpox)

    • measles

    • hepatitis B

    • pneumococcus

    • influenza, and

    • varicella zoster (if ≥ 50 years old).

      • Note: If subjects require administration of either live or killed vaccines to meet eligibility requirements, they must wait at least 2 weeks between vaccination and the baseline visit (i.e., at least 4 weeks before initiation of therapy)

Living Donor Inclusion Criteria:

Living donors must meet all of the following criteria to be eligible-

  1. Able to understand and provide informed consent for research
  2. Meets United Network for Organ Sharing (UNOS) requirements for kidney organ donation

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study subjects-

  1. Inability or unwillingness of a subject to give written informed consent or comply with study protocol

  2. Known active current or history of invasive fungal infection, non-tuberculous mycobacterial infection

  3. Hepatitis B surface antigen or core antibody positive

  4. Serious uncontrolled concomitant major organ disease, excluding kidney failure

  5. Chronic respiratory failure

  6. Uncontrolled systemic hypertension

  7. Previous non-kidney solid organ transplant or bone marrow transplant

  8. Any infection requiring hospitalization and intravenous (IV) therapy within 4 weeks of screening or oral therapy within 2 weeks of screening

  9. Primary or secondary immunodeficiency

  10. History of thromboembolism (except thrombosis of dialysis vascular access site)

  11. Subjects with myocardial infarction within 12 months of screening or cardiac dysrhythmias uncontrolled by medications

  12. History of plasma cell dyscrasia

  13. Known bleeding diathesis or coagulation abnormality

  14. History of active tuberculosis (TB) (even if treated)

  15. Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated cervical cancer in situ

  16. Women who are currently pregnant or nursing

  17. Alcohol, drug, or chemical abuse within 1 year

  18. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening

  19. Current treatment with other biological drug. If the potential subject receives standard of care antibody treatments for prophylaxis of COVID-19 (permitted in protocol), there must be a minimum interval of 2 weeks after this treatment and before initiation of the study therapy.

  20. Current treatment with any medication which increases the risk of thromboembolic events including oral contraceptives

  21. Currently smoking tobacco

  22. Neutropenia (absolute neutrophil count <1000/microliter) or thrombocytopenia (platelet count <100,000/microliter) within 4 weeks prior to screening

  23. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times upper limit of normal (ULN) or total bilirubin ≥ 2 times ULN

  24. Past or current medical problems or findings from physical examination or laboratory testing not listed above, which, in the opinion of the investigator, may:

    • pose additional risks from participation in the study
    • interfere with the subject's ability to comply with study requirements, or
    • impact the quality or interpretation of the data obtained from the study.

Exclusion Criteria for Living Donors:

1. There are no exclusion criteria for living donors.

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: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cohort 1

The two investigational agents used in this study are carfilzomib and belatacept.

Per protocol, Carfilzomib administered intravenously:

  • Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43).
  • Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99).

Per protocol, Belatacept:

-Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert.
Biológico: carfilzomib

Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.

Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.

Outros nomes:
  • Kyprolis®
Biológico: belatacept

Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.

Outros nomes:
  • Nulojix®
Procedimento: Bone marrow aspiration

Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.
Experimental: Cohort 2

The enrollment of ten additional subjects and dosing regimen is dependent on the results in Cohort 1.°

Per protocol, Carfilzomib administered intravenously:

  • Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43).
  • Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99).

Per protocol, Belatacept:

-Belatacept will be administered intravenously on days 28 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert.

° May be modified based on the safety and efficacy analysis of Cohort 1.
Biológico: carfilzomib

Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.

Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.

Outros nomes:
  • Kyprolis®
Biológico: belatacept

Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.

Outros nomes:
  • Nulojix®
Procedimento: Bone marrow aspiration

Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through 20 weeks (Cohort 1) after starting treatment or until receiving a transplant, whichever occurs earlier.
Prazo: Up to 26 weeks post treatment initiation

Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 26 post treatment initiation or until receiving a transplant, whichever occurs earlier:

  1. Grade 3 or higher infusion reaction,
  2. Grade 3 or higher infections, and
  3. Any malignancy.

The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017).
Up to 26 weeks post treatment initiation
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through Week 24 (Cohort 2) post treatment initiation or until receiving a transplant, whichever occurs earlier.
Prazo: Up to 24 weeks post treatment initiation

Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 24 post treatment initiation or until receiving a transplant, whichever occurs earlier:

  1. Grade 3 or higher infusion reaction,
  2. Grade 3 or higher infections, and
  3. Any malignancy.

The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017).
Up to 24 weeks post treatment initiation
Proportion of subjects who achieve any one of the following compared to Baseline - Cohort 1
Prazo: Baseline (Visit 0) to Week 20 post treatment initiation

Proportion of subjects who achieve any one of the following compared to Baseline (Visit 0):

  1. Elimination of one human leukocyte antigen (HLA) antibody at Week 20 (which is Study Week 24) post treatment initiation,
  2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 20 (which is Study Week 24) after starting treatment, and/or
  3. Kidney transplant with a previously incompatible donor within 20 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response.
Baseline (Visit 0) to Week 20 post treatment initiation
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 24 post treatment initiation - Cohort 2
Prazo: Baseline (Visit 0) to Week 24 post treatment initiation

Proportion of subjects who meet any one of the following compared to Baseline (Visit 0):

  1. Elimination of one human leukocyte antigen (HLA) antibody at Week 24 (which is Study Week 28) post treatment initiation,
  2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 24 (which is Study Week 28) after starting treatment, and/or
  3. Kidney transplant with a previously incompatible donor within 52 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response.
Baseline (Visit 0) to Week 24 post treatment initiation

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Número de eventos de infeção por citomegalovírus (CMV) nas 24 semanas após o início do tratamento
Prazo: Dentro de 24 semanas após o início do tratamento
Dentro de 24 semanas após o início do tratamento
Número de eventos de infeção por citomegalovírus (CMV) dentro de 52 semanas após o início do tratamento
Prazo: Dentro de 52 semanas após o início do tratamento
Dentro de 52 semanas após o início do tratamento
Número de eventos de doença linfoproliferativa pós-transplante (PTLD) dentro de 52 semanas após o transplante
Prazo: Até 52 semanas após o transplante
Até 52 semanas após o transplante
Proporção de sujeitos transplantados com um dador a quem o anticorpo específico do dador (DSA) foi previamente positivo e reduzido em ≥50% no momento do transplante dentro de 52 semanas após o início do tratamento
Prazo: No prazo de 52 semanas após o transplante
No prazo de 52 semanas após o transplante
Proportion of subjects transplanted with a DSA-negative donor to whom DSA was previously positive, within 52 weeks after starting treatment
Prazo: Within 52 weeks post treatment initiation

Clinical outcome measure.

Subjects may receive a kidney transplant while in the study, either from a living or deceased donor to whom they were previously compatible, or from a previously incompatible donor in case there is a significant reduction in HLA antibody.
Within 52 weeks post treatment initiation
Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks post-transplant in subjects who undergo a kidney transplant
Prazo: Within 52 weeks post-transplant

Clinical outcome measure.

Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies.
Within 52 weeks post-transplant
Number of biopsy-proven acute or chronic AMR events within 52 weeks post-transplant in subjects who undergo a kidney transplant
Prazo: Within 52 weeks post-transplant

Clinical outcome measure.

Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies.
Within 52 weeks post-transplant
Proportion of subjects with invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 24 weeks after starting treatment
Prazo: Within 24 weeks post treatment initiation

A measure of infection-related morbidity.
Within 24 weeks post treatment initiation
Proportion of subjects with invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment
Prazo: Within 52 weeks post treatment initiation

A measure of infection-related morbidity.
Within 52 weeks post treatment initiation
Number of invasive fungal infections, mycobacterial infections, or Pneumocystis jirovecii infection events within 24 weeks after starting treatment
Prazo: Within 24 weeks post treatment initiation

A measure of infection-related morbidity.
Within 24 weeks post treatment initiation
Number of invasive fungal infections, mycobacterial infections, or Pneumocystis jirovecii infection events within 52 weeks after starting treatment
Prazo: Within 52 weeks post treatment initiation

A measure of infection-related morbidity.
Within 52 weeks post treatment initiation
Proportion of subjects with cytomegalovirus (CMV) infection and disease within 24 weeks after starting treatment
Prazo: Within 24 weeks post treatment initiation

CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present.
Within 24 weeks post treatment initiation
Proportion of subjects with cytomegalovirus (CMV) infection and disease within 52 weeks after starting treatment
Prazo: Within 52 weeks post treatment initiation

CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present.
Within 52 weeks post treatment initiation
Proportion of subjects with post-transplant lymphoproliferative disorder (PTLD) within 52 weeks post-transplant
Prazo: Within 52 weeks post-transplant

As per diagnosis by local pathologist and treating physician.
Within 52 weeks post-transplant
Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated at 16 weeks compared to Baseline (Cohort 1)
Prazo: Baseline (Visit 0), Week 16 post treatment initiation

Mechanistic outcome measure focusing on change in donor specific antibodies (DSA).
Baseline (Visit 0), Week 16 post treatment initiation
Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated at 52 weeks compared to Baseline (Cohort 2)
Prazo: Baseline (Visit 0), Week 52 post treatment initiation

Mechanistic outcome measure focusing on change in donor specific antibodies (DSA).
Baseline (Visit 0), Week 52 post treatment initiation
Mean percentage of Human Leukocyte Antigen (HLA) antibodies eliminated at 16 weeks compared to Baseline (Cohort 1)
Prazo: Baseline (Visit 0), Weeks 16, and 52 post treatment initiation

Mechanistic outcome measure focusing on change in donor specific antibodies (DSA).
Baseline (Visit 0), Weeks 16, and 52 post treatment initiation
Mean percentage of Human Leukocyte Antigen (HLA) antibodies eliminated at 52 weeks compared to Baseline (Cohort 2)
Prazo: Baseline (Visit 0), Weeks 16, and 52 post treatment initiation

Mechanistic outcome measure focusing on change in donor specific antibodies (DSA).
Baseline (Visit 0), Weeks 16, and 52 post treatment initiation

Colaboradores e Investigadores

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

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Colaboradores

Bristol-Myers Squibb
Rho Federal Systems Division, Inc.
Immune Tolerance Network (ITN)
PPD Development, LP

Investigadores

  • Cadeira de estudo: Stuart J. Knechtle, MD, Duke Department of Surgery, Duke University School of Medicine
  • Cadeira de estudo: Annette M. Jackson, PhD, Duke Department of Surgery, Duke University School of Medicine

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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)

28 de dezembro de 2021

Conclusão Primária (Real)

5 de agosto de 2026

Conclusão do estudo (Estimado)

1 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

17 de agosto de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de agosto de 2021

Primeira postagem (Real)

24 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DAIT ITN089ST
  • ITN089ST (Outro identificador: Immune Tolerance Network (ITN))
  • NIAID CRMS ID#: 38685 (Outro identificador: DAIT NIAID)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Prazo de Compartilhamento de IPD

On average, within 24 months after database lock for the trial.

Critérios de acesso de compartilhamento IPD

Open access.

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

Não

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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