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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Biological: ChoironeX GalKO Porcine Thymokidney

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lindsey Dickerson; Phone Number: +1 (347) 602-0721; Email: ldickerson@nefro-avillion.com
• Study Contact Backup: Name: Gemma Hodgson; Email: ghodgson@nefro-avillion.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Study Site 2
      • Contact: Research Coordinator
    • New York, New York, United States, 10032
      • Study Site 1
      • Contact: Research Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Porcine Thymokidney; Porcine Thymokidney transplanted into patients with End Stage Renal Disease	Biological: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xeno Holdings (US), LLC dba ChoironeX
• Investigators: Study Director: Anh Nyugen, MD, ChoironeX / Our Hybrid Concepts LLC

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Kidney, Porcine, Xeno-Transplant
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: CHX-01-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No