Study of GGTA1 KO Thymokidney Transplantation Safety and Effectiveness in Adults Aged 40 to 70 With End-Stage Kidney Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the GGTA1 KO Thymokidney, a genetically modified porcine kidney with thymic tissue, in patients with end-stage renal disease ESRD who are either not eligible for traditional kidney transplants or are on a transplant waitlist but face a high risk of dying or not receiving a transplant within five years. This Phase 12 multicenter, open-label study aims to assess outcomes such as patient survival, kidney function, and quality of life following xenotransplantation. Participants will receive the GGTA1 KO Thymokidney transplant and undergo a 24-week post-transplant follow-up period to evaluate safety and study endpoints. Following this, participants enter a long-term follow-up phase lasting for their lifetime or up to 52 weeks after nephrectomy if needed. The study includes two groups based on transplant eligibility and risk status, with treatments delivered through xenotransplantation procedures. Participants will be closely monitored through regular assessments including survival rates, kidney function tests measuring glomerular filtration rate, quality of life questionnaires, and screening for infections. Safety is tracked by recording adverse events, proteinuria, and infections over time. The study involves a screening period of up to 52 weeks before transplantation and continuous long-term monitoring extending potentially up to 50 years, ensuring comprehensive evaluation of both patient and transplanted kidney outcomes.

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