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NCT Number: NCT07696962

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study Site 1, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ChoironeX GalKO Porcine Thymokidney

Biological

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.

Primary outcomes

  1. Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.

    Time frame: 6 months

  2. Overall survival of the recipient without the need for chronic dialysis at Month 6.

    Time frame: 6 months

Secondary outcomes

  1. Overall survival without the need for dialysis at Month 3.

    Time frame: 3 months

  2. Graft survival free from hyperacute rejection at Day 3.

    Time frame: 3 Days

  3. Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6.

    Time frame: 6 months

  4. Banff classification of xenograft pathology at biopsy.

    Time frame: 6 months

  5. Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6.

    Time frame: 6 months

  6. Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6.

    Time frame: 6 months

  7. Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6

    Time frame: 6 months

  8. Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6.

    Time frame: 6 months

  9. Change from baseline in blood pressure at Months 3 and 6.

    Time frame: 6 months

  10. Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts.

    Time frame: 6 months

  11. Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects.

    Time frame: 6 months

  12. Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6.

    Time frame: 6 months

  13. New-onset diabetes after transplant (NODAT) through Month 6.

    Time frame: 6 months

  14. Change from baseline in BMI at Months 3 and 6.

    Time frame: 6 months

  15. Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the EuroQol 5-Dimension 5-Level Questionnaire.

    Time frame: 6 months

  16. 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.

    Time frame: 6 months

  17. Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire.

    Time frame: 6 months

  18. Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Patient Global Impression of Change Questionnaire.

    Time frame: 6 months

  19. Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA).

    Time frame: 6 months

  20. Duration of initial hospitalization.

    Time frame: 6 months

  21. Duration of ICU care during initial hospitalization.

    Time frame: 6 months

  22. Number of hospitalizations through Month 6.

    Time frame: 6 months

  23. Time to thymokidney explant, and time to restarting dialysis after explant (if relevant).

    Time frame: 6 months

  24. Incidence of temporary dialysis treatments through Month 6.

    Time frame: 6 months

  25. Number of dialysis-free days through Month 6.

    Time frame: 6 months

  26. Time from transplant to first dialysis treatment (if relevant).

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Gemma Hodgson

CONTACT

[email protected]

Lindsey Dickerson

CONTACT

[email protected]

+1 (347) 602-0721

Sponsors and collaborators

Lead sponsor

Xeno Holdings (US), LLC dba ChoironeX

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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