NCT07696962

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
26mo left

Started Jul 2026

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Sep 2028

First Submitted

Initial submission to the registry

May 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

May 28, 2026

Last Update Submit

July 8, 2026

Conditions

End Stage Renal Disease

Keywords

Kidney, Porcine, Xeno-Transplant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (26)

  • 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

  • +21 more secondary outcomes

Study Arms (1)

Porcine Thymokidney

EXPERIMENTAL

Porcine Thymokidney transplanted into patients with End Stage Renal Disease

Biological: ChoironeX GalKO Porcine Thymokidney

Interventions

ChoironeX GalKO Porcine ThymokidneyBIOLOGICAL

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.

Porcine Thymokidney

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Study Site 2

New York, New York, 10016, United States

Location

Study Site 1

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anh Nyugen, MD

    ChoironeX / Our Hybrid Concepts LLC

    STUDY DIRECTOR

Central Study Contacts

Lindsey Dickerson

CONTACT

+1 (347) 602-0721ldickerson@nefro-avillion.com

Gemma Hodgson

CONTACT

ghodgson@nefro-avillion.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

July 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)