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Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

8. juli 2026 opdateret af: Xeno Holdings (US), LLC dba ChoironeX

Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

4

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • Study Site 2
        • Kontakt:
          • Research Coordinator
      • New York, New York, Forenede Stater, 10032
        • Study Site 1
        • Kontakt:
          • Research Coordinator

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  • ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months
  • Eligible for kidney transplantation per site criteria
  • <50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
  • Blood type and immunologic compatibility with study transplant confirmed by testing
  • EBV seropositive
  • Up to date on recommended vaccinations for immunocompromised individuals
  • Willing to use protocol-required contraception
  • Able to provide informed consent and comply with lifelong follow-up

Exclusion Criteria:

  • Requirement for multi-organ transplantation
  • Living donor available who is ABO-incompatible
  • Kidney disease with high risk of post-transplant recurrence
  • Polycystic kidney disease without prior native nephrectomy
  • Unable or unwilling to comply with study procedures
  • History of non-adherence to medical treatment
  • Identified as vulnerable by psychological assessment
  • Significant uncontrolled psychiatric illness
  • Inadequate social support or caregiver unavailable/unwilling
  • Current drug or alcohol misuse
  • Serious non-renal illness with life expectancy <1 year
  • BMI <16 or >35 kg/m²
  • Known hypercoagulable disorder
  • Uncontrolled hypertension or hemodynamic instability at enrollment
  • Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment
  • Serious liver disease or impaired liver function
  • Diabetes mellitus with poor glycemic control (HbA1c >10%)
  • Active infection at time of transplantation
  • Positive serology for hepatitis B, hepatitis C, or HIV
  • Current, active, or untreated tuberculosis
  • Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer
  • Current systemic immunosuppressive therapy (excluding permitted corticosteroids)
  • Participation in another interventional drug trial within 60 days prior to enrollment
  • Pregnant or breastfeeding
  • Known severe hypersensitivity to a required study medication with no acceptable alternative

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Porcine Thymokidney
Porcine Thymokidney transplanted into patients with End Stage Renal Disease
Biologisk: ChoironeX GalKO Porcine Thymokidney
A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
Tidsramme: 6 months
6 months
Overall survival of the recipient without the need for chronic dialysis at Month 6.
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Overall survival without the need for dialysis at Month 3.
Tidsramme: 3 months
3 months
Graft survival free from hyperacute rejection at Day 3.
Tidsramme: 3 Days
3 Days
Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6.
Tidsramme: 6 months
6 months
Banff classification of xenograft pathology at biopsy.
Tidsramme: 6 months
6 months
Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6.
Tidsramme: 6 months
6 months
Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6.
Tidsramme: 6 months
6 months
Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6
Tidsramme: 6 months
6 months
Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6.
Tidsramme: 6 months
6 months
Change from baseline in blood pressure at Months 3 and 6.
Tidsramme: 6 months
6 months
Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts.
Tidsramme: 6 months
6 months
Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects.
Tidsramme: 6 months
6 months
Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6.
Tidsramme: 6 months
6 months
New-onset diabetes after transplant (NODAT) through Month 6.
Tidsramme: 6 months
6 months
Change from baseline in BMI at Months 3 and 6.
Tidsramme: 6 months
6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the EuroQol 5-Dimension 5-Level Questionnaire.
Tidsramme: 6 months
6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Standardized Outcomes in Nephrology Life Subject Questionnaire.
Tidsramme: 6 months
6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire.
Tidsramme: 6 months
6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Patient Global Impression of Change Questionnaire.
Tidsramme: 6 months
6 months
Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA).
Tidsramme: 6 months
6 months
Duration of initial hospitalization.
Tidsramme: 6 months
6 months
Duration of ICU care during initial hospitalization.
Tidsramme: 6 months
6 months
Number of hospitalizations through Month 6.
Tidsramme: 6 months
6 months
Time to thymokidney explant, and time to restarting dialysis after explant (if relevant).
Tidsramme: 6 months
6 months
Incidence of temporary dialysis treatments through Month 6.
Tidsramme: 6 months
6 months
Number of dialysis-free days through Month 6.
Tidsramme: 6 months
6 months
Time from transplant to first dialysis treatment (if relevant).
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xeno Holdings (US), LLC dba ChoironeX

Efterforskere

  • Studieleder: Anh Nyugen, MD, ChoironeX / Our Hybrid Concepts LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. maj 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHX-01-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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