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10 GE Xenokidney · EXPAND

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

Ensayo de UNITED THERAPEUTICS Corp en ESRD (End-Stage Renal Disease) · Kidney Transplantation · Xenotransplantation (del registro, en inglés).

Fase

Fase 1/2

Estado

Reclutando pacientes

Participantes

50

previstos

Centros

2

Fin del objetivo primario

oct 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2025.

Qué mide

Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant (Day 0 (day of xenotransplantation) to 24 weeks post transplant) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de UTHR

Todos los de UTHR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06878560), actualizada en mar 2026.