Study to Assess Safety and Effectiveness of 10 GE Xenokidney Transplant in Adults With End-Stage Renal Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the 10 GE Xenokidney in people with end-stage renal disease ESRD who either cannot have a conventional kidney transplant or are on a transplant waitlist but face a high risk of dying or not receiving a transplant within five years. This multicenter, open-label Phase 12 study aims to provide new options for these patients by using a genetically modified pig kidney for transplantation. Participants will receive the 10 GE Xenokidney transplant, followed by a 24-week post-transplant period to monitor safety and treatment outcomes. After this, there is a long-term follow-up period lasting for the participants lifetime to observe survival, kidney function, and to check for infections that could be passed from animals to humans. The study includes two groups one with patients ineligible for traditional transplants and another with patients on the transplant waitlist but unlikely to receive a kidney soon. During the study, participants will undergo screenings, regular safety assessments, and evaluations of kidney function and quality of life using standardized questionnaires. Researchers will monitor for adverse events, infections, and proteinuria throughout the study. The main outcomes include patient and kidney survival rates at 24 weeks, long-term survival, and kidney function measures. Participants will be followed closely for many years to gather important long-term safety and effectiveness data.

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