Porcine Thymokidney Transplant for Kidney Failure

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Overseen ByAnna Danilewicz
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with severe kidney failure by testing whether a special pig kidney, known as a ChoironeX GalKO Porcine Thymokidney, can function without dialysis. Researchers aim to determine if this transplant can support kidney function for those already on dialysis and unlikely to receive a standard donor kidney soon. Candidates who have been on dialysis for at least six months and have a compatible blood type with the pig kidney may qualify for this trial. As a Phase 1 trial, the research focuses on understanding how this new treatment works in humans, offering participants the chance to be among the first to receive this innovative therapy.

What prior data suggests that this Porcine Thymokidney is safe for humans?

Previous studies have shown promise for specially modified pig kidneys, such as the ChoironeX GalKO Porcine Thymokidney, in lab settings. Research suggests these pig kidneys are unlikely to face immediate rejection after transplantation into humans, indicating potential initial tolerance. However, as the trial is in an early stage, detailed safety information in humans remains limited. This phase primarily tests safety, and more information will emerge as the trial progresses.12345

Why do researchers think this study treatment might be promising for kidney failure?

Unlike the standard of care for kidney failure, which often includes dialysis or human kidney transplants, the Porcine Thymokidney transplant uses a genetically modified pig kidney. Researchers are excited about this treatment because it introduces a new approach by using the ChoironeX GalKO Porcine Thymokidney, which has been altered to reduce the risk of rejection by the human immune system. This innovative method has the potential to address the shortage of human organs available for transplantation, offering new hope for patients with End Stage Renal Disease.

What evidence suggests that the ChoironeX GalKO Porcine Thymokidney might be an effective treatment for End Stage Renal Disease?

Research has shown that using pig kidneys for transplants holds promise for maintaining stable kidney function. In one study, a patient lived for 271 days with a pig kidney, marking the longest recorded duration. Gene-edited pig kidneys have also functioned successfully in some animals for over a year without issues. This trial will evaluate the Porcine Thymokidney, an experimental treatment for patients with End Stage Renal Disease. Using pigs as donors is gaining popularity because it could help address the shortage of human kidneys available for transplant.678910

Who Is on the Research Team?

AN

Anh Nyugen, MD

Principal Investigator

ChoironeX / Our Hybrid Concepts LLC

Are You a Good Fit for This Trial?

This trial is for adults with end-stage kidney failure who need a new kidney and are eligible for transplantation. Participants should be healthy enough to undergo surgery and not have conditions that would make the transplant unsafe.

Inclusion Criteria

Blood type and immunologic compatibility with study transplant confirmed by testing
I am eligible for a kidney transplant at this hospital.
Less than 50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
See 5 more

Exclusion Criteria

Positive serology for hepatitis B, hepatitis C, or HIV
I do not have uncontrolled high blood pressure or unstable blood flow.
Inadequate social support or caregiver unavailable/unwilling
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Porcine Thymokidney is transplanted into patients with End Stage Renal Disease

1 week

Post-Transplant Monitoring

Participants are monitored for renal function and overall health post-transplantation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • ChoironeX GalKO Porcine Thymokidney

Trial Overview

The study is testing whether a specially modified pig kidney (GalKO Porcine Thymokidney) can safely replace human kidney function in people with severe kidney failure, so they no longer need dialysis.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Porcine ThymokidneyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xeno Holdings (US), LLC dba ChoironeX

Lead Sponsor

Citations

Study of ChoironeX GalKO Porcine Thymokidney ...

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 ...

The First Clinical Renal Xenotransplantation Study (EXPAND)

The patient survived 271 days, representing the longest reported survival following a pig‐to‐human kidney xenotransplantation. Previous ...

First Gene-Edited Pig Kidney Transplant Clinical Trial ...

Efficacy end points include participant survival rate, UKidney survival rate, change in measured glomerular filtration rate, and change in ...

Porcine Kidney Xenotransplantation in Patients With End- ...

We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease.

Study of ChoironeX GalKO Porcine Thymokidney ...

The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, ...

Regenerative Medicine: What Is Actually Approved | CureMed

Multiple Phase 3 programmes and a curative signal in previously untreatable disease. The FDA cited 22 reported secondary T-cell cancers as of 31 December 2023, ...

Physiology and immunology of pig-to-human decedent ...

Xenotransplantation of genetically-modified pig kidneys offers a solution to the scarcity. 76 of organs for end-stage renal disease patients.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34800323/

Genetically engineered pig kidney transplantation in a brain ...

(ii) Numerous in vitro studies have predicted that a GTKO pig kidney would not be rejected within the first few days after transplantation into ...

Southlake Regional Health Centre Trials

Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease. Anti-Cancer Therapies Active, not recruiting. Patient Population ...

Dorset County Hospital NHS Foundation Trust Trials

ChoironeX GalKO Porcine Thymokidney. Xeno Holdings (US), LLC dba ChoironeX. End Stage Renal Disease. 05/28. 09/28. AURORA, NCT06453668 / 2023-506174-12-00: A ...