Recruiting
Phase 1

GalKO Porcine Thymokidney

Sponsor:

Xeno Holdings (US), LLC dba ChoironeX

Code:

NCT07696962

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ChoironeX GalKO Porcine Thymokidney

Study Details

Brief summary:

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.

Conditions

End Stage Renal Disease

Study ID

NCT07696962

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Porcine Thymokidney

Porcine Thymokidney transplanted into patients with End Stage Renal Disease

Interventions

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.

Primary outcome measure

  • 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 ]
  • Overall survival of the recipient without the need for chronic dialysis at Month 6. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Gemma Hodgson

443-842-0861ghodgson@xeno-holdings.com

Anna Danilewicz

662-300-9413adanilewicz@xeno-holdings.com

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Xenotransplant Team

929-831-0135

More Information

Sponsor

Xeno Holdings (US), LLC dba ChoironeX

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • Kidney, Porcine, Xeno-Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Xeno Holdings (US), LLC dba ChoironeX on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.