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GGTA1 KO Thymokidney · EXTEND

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney 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

1

Fin del objetivo primario

nov 2029

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en nov 2026.

Lo que ha cambiado

Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.

Qué mide

Survival Rate of Patients with ESRD Receiving the GGTA1 KO Thymokidney 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 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.

Más ensayos de UTHR

Todos los de UTHR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07224763), actualizada en sep 2026.