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Carfilzomib og Belatacept for desensibilisering (ADAPT)

2. november 2026 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)

Måling av virkningen av Carfilzomib og Belatacept på allogen desensibilisering hos potensielle nyretransplantasjonsmottakere (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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke Transplant Center, Duke University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: 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.

Andre navn:
  • Kyprolis®
Biologisk: 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.

Andre navn:
  • Nulojix®
Fremgangsmåte: 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.
Eksperimentell: 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.
Biologisk: 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.

Andre navn:
  • Kyprolis®
Biologisk: 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.

Andre navn:
  • Nulojix®
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall cytomegalovirus (CMV) infeksjonshendelser innen 24 uker etter behandlingsstart
Tidsramme: Innen 24 uker etter behandlingsstart
Innen 24 uker etter behandlingsstart
Antall cytomegalovirus (CMV)-infeksjonshendelser innen 52 uker etter behandlingsstart
Tidsramme: Innen 52 uker etter behandlingsstart
Innen 52 uker etter behandlingsstart
Antall hendelser med post-transplantasjons lymfoproliferativ lidelse (PTLD) innen 52 uker etter transplantasjon
Tidsramme: Innen 52 uker etter transplantasjon
Innen 52 uker etter transplantasjon
Andel av forsøkspersoner som ble transplantet med en donor som donorspesifikt antistoff (DSA) tidligere var positivt for og ble redusert med ≥50% ved transplantasjonstidspunktet innen 52 uker etter behandlingsstart
Tidsramme: Innen 52 uker etter transplantasjon
Innen 52 uker etter transplantasjon
Proportion of subjects transplanted with a DSA-negative donor to whom DSA was previously positive, within 52 weeks after starting treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. desember 2021

Primær fullføring (Faktiske)

5. august 2026

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

17. august 2021

Først innsendt som oppfylte QC-kriteriene

17. august 2021

Først lagt ut (Faktiske)

24. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DAIT ITN089ST
  • ITN089ST (Annen identifikator: Immune Tolerance Network (ITN))
  • NIAID CRMS ID#: 38685 (Annen identifikator: DAIT NIAID)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

Open access.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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