RecruitingPhase 1Phase 2NCT07224763

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

EXTEND: A Prospective Study to Evaluate the Safety and Efficacy of GGTA1 KO Thymokidney XenoTransplantation in Patients With End-stage Renal Disease (ESRD)

Sponsor

United Therapeutics

Enrollment

50 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Kidney Transplantation Xenotransplantation ESRD (End-Stage Renal Disease)

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a genetically modified pig kidney (a xenotransplant) combined with thymus tissue in people with end-stage kidney disease (ESRD) who are on dialysis. The pig has been engineered to remove a sugar molecule that normally causes human immune rejection, and the thymus tissue is included to help the immune system accept the foreign organ. **You may be eligible if...** - You are between 40 and 70 years old (or 40–49 if you have very high antibody levels making a human kidney transplant very unlikely) - You have end-stage kidney disease and have been on dialysis for at least 6 months - Your thymus gland has shrunk naturally with age (confirmed by CT scan) - You live within 3 hours of the transplant center - Female participants must be post-menopausal or permanently sterilized - You have an acceptable estimated post-transplant survival score **You may NOT be eligible if...** - You have a positive crossmatch result against the pig donor tissue - You have a BMI above the study limit - You are unable to comply with lifelong follow-up requirements - You have significant active medical or psychiatric conditions affecting your ability to safely participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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