RecruitingPhase 1Phase 2NCT06878560

Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD

EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)

Sponsor

United Therapeutics

Enrollment

50 participants

Start Date

Oct 29, 2025

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 10 GE Xenokidney in patients with 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, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This groundbreaking study tests a pig kidney — genetically modified in 10 specific ways — as a transplant option for people with end-stage kidney disease (ESRD) who are on dialysis. The goal is to evaluate whether a genetically engineered animal kidney can safely function in the human body long-term. **You may be eligible if:** - You have been diagnosed with end-stage kidney disease (ESRD) - You have been on dialysis for at least 6 months and have a functioning access site (fistula, graft, or catheter) - You meet additional health and suitability criteria as assessed by the study team - You are willing to be followed for the rest of your life as part of the study **You may NOT be eligible if:** - You have active infections or conditions that would make transplant surgery unsafe - You have a history of conditions that significantly raise rejection risk - You are pregnant - You are unwilling or unable to commit to lifelong follow-up 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.

Interested in this trial?

Get notified about updates and connect with the research team.