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NCT06878560 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
A Phase 1 study of Kidney Transplantation and ESRD (End-Stage Renal Disease), sponsored by United Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06878560 is a Phase 1 study of Kidney Transplantation and ESRD (End-Stage Renal Disease) that is actively recruiting participants, run by United Therapeutics. The registered enrollment target is 50 participants, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06878560, a Phase 1 study of Kidney Transplantation and ESRD (End-Stage Renal Disease), is actively recruiting participants, sponsored by United Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL 10 GE Xenokidney
Study Locations (1)
New York
- New York University Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2075-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06878560
The ClinicalTrials.gov registry entry for NCT06878560 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (81% lower). The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Kidney Transplantation appearing as the primary indexed condition, and to 1 intervention - of which 10 GE Xenokidney is the first listed.
NCT06878560 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06878560 about?
NCT06878560 is a clinical study titled "Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD". 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 ar...
What is the current status of trial NCT06878560?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-10-29. Estimated completion is 2075-10.
What conditions does trial NCT06878560 study?
This clinical trial studies the following conditions: Kidney Transplantation, ESRD (End-Stage Renal Disease), Xenotransplantation.
What interventions are being tested in trial NCT06878560?
The interventions under investigation include: 10 GE Xenokidney (BIOLOGICAL).
Who is sponsoring clinical trial NCT06878560?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06878560 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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