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What is this study?

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•You have ESRD and agree to take part voluntarily, including long-term (lifetime) follow-up.
•You are on hemodialysis for at least 6 months and have a working fistula/graft or a permanent catheter.
•Your age is 50 to 70, or 40 to less than 50 with a cPRA of 99.9% or higher (cPRA is a test that estimates how hard it may be to match a donor).
•A chest CT scan shows thymic involution with a thymic region of interest score of 1 or less (thymic involution is a thinning/shrinking of the thymus as people age).
•Your body mass index (BMI) is 35 or less, and you have had recommended meningococcal and other CDC-recommended vaccines, and you test positive for CMV and EBV (CMV = cytomegalovirus; EBV = Epstein-Barr virus).

🚫 You may not be able to join if…

•You need multiple organ transplants.
•You have severe medical problems, such as advanced heart disease, severe peripheral vascular disease that would block the transplant, severe lung problems needing oxygen, pulmonary hypertension, uncontrolled diabetes, severe neurologic disease affecting recovery/consent, or severe chronic liver disease.
•Your ESRD is caused by hereditary or structural kidney disease.
•You have current or recently treated cancer, or a blood/anemia disorder not caused by kidney issues (for example thalassemia or sickle disease).
•You cannot stop certain long-term blood thinners (low-dose daily aspirin is allowed). Also not allowed: active/recent TB, hepatitis B/C infection by specific tests, HIV infection, recent major psychiatric hospitalization/suicidal thoughts, or you cannot do daily activities by yourself.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 40–70
✓Have Obesity / overweight

!Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections.

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD