Study of 10 GE Xenokidney for End-Stage Renal Disease
This study is testing a new type of kidney transplant called the 10 GE Xenokidney, which comes from pigs and has been specially modified. It's for people with end-stage renal disease (ESRD), also known as kidney failure. The study wants to see how safe and effective this xenokidney is. We're looking at how long patients and the xenokidney survive after the transplant, specifically at 24 weeks. You might be able to join if you are between 40 and 70 years old, have ESRD, and have been on dialysis for at least 6 months. This study is for people who can't get a traditional human kidney transplant or are on a transplant waitlist but are unlikely to get a kidney soon. The study aims to enroll 50 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It will involve 50 participants across two groups.
- What's involved
- You would undergo the 10 GE Xenokidney transplantation, followed by a 24-week follow-up period. After that, there will be a long-term follow-up that continues for your lifetime.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 24 weeks after transplantation, and then for the rest of their lives to monitor survival and check for infections.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
At a glance
Conditions
NCT06878560
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
New York University Langone Health
New York, New Yorkstudy coordinator listed
Recruiting
Northwestern Memorial Hospital
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post TransplantDay 0 (day of xenotransplantation) to 24 weeks post transplant
Participant survival rate at 24 weeks post transplant.
- Survival Rate of the 10 GE Xenokidney at 24 Weeks Post TransplantDay 0 (day of xenotransplantation) to 24 weeks post transplant
10 GE Xenokidney survival rate at 24 weeks post transplant. 10 GE Xenokidney failure is defined as 10 GE Xenokidney nephrectomy.
- Survival Time of Participants Receiving the 10 GE XenokidneyDay 0 (day of xenotransplantation) until death for any cause, assessed at least every 24 weeks after transplantation while the participant is alive, up to 50 years
Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause
- Survival Time of the 10 GE Xenokidney (Overall Survival)Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years
Overall survival of the 10 GE Xenokidney post transplant. Overall survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy or death, whichever occurs first.
- Survival Time of the 10 GE Xenokidney (Death-censored Survival)Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years
Death-censored survival 10 GE Xenokidney. Death-censored survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy censored for death.
- 10 GE Xenokidney Function Post Transplant (Endogenous GFR)At 24 weeks post transplant
Endogenous measured GFR (24-hour urine creatinine clearance) at 24 weeks post transplant.
- 10 GE Xenokidney Function Post Transplant (Exogenous GFR)At 24 weeks post transplant
Exogenous measured GFR (nuclear medicine GFR) at 24 weeks post transplant.
- Quality of Life in Participants Receiving the 10 GE Xenokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L)Baseline to 24 weeks post transplant
Change in the EQ-5D-5L from baseline to 24 weeks post transplant. The EQ-5D-5L questionnaire assesses health-related quality of life across 5 categories (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression). Each category has 5 levels, ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Higher scores indicate a worse health outcome (more mobility issues, greater pain, more anxiety, etc).
- Quality of Life in Participants Receiving the 10 GE Xenokidney by Standardized Outcomes in Nephrology Life Participant (SONG-LP)Baseline to 24 weeks post transplant
Change in SONG-LP from baseline to 24 weeks post transplant. The SONG-LP assesses participation in different life activities over the past month. The minimum score (worst outcome) is 4 (if all responses are "1" - Never) and the maximum score (best outcome) is 20 (if all responses are "5" - Always). Higher scores indicate a better health outcome (greater ability to participate in activities).
- Quality of Life in Participants Receiving the 10 GE Xenokidney by Kidney Transplant Questionnaire (KTQ)Baseline to 24 weeks post transplant
Change in KTQ from baseline to 24 weeks post transplant. Each question in the KTQ is scored on a 1 to 7 scale with: 1 = worst outcome (eg, "A very great deal of trouble or distress" / "All of the time") and 7 = best outcome (eg, "No trouble or distress" / "None of the time"). Higher scores indicate a better outcome, meaning less distress, fewer symptoms, and better well-being.
- Quality of Life in Participants Receiving the 10 GE Xenokidney by Patient Global Impression of Change (PGI-C)At 24 weeks post transplant
PGI-C at 24 weeks post transplant. The PGI-C assesses a patient's perception of improvement or worsening over time. The minimum score (best outcome) is 1 ("Very Much Improved") and the maximum score (worst outcome) is 7 ("Very Much Worse"). Higher scores indicate a worse health outcome (greater worsening).
- Incidence of Treatment-Emergent Adverse Events (Safety of the 10 GE Xenokidney)Baseline until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of adverse events and serious adverse events; all-cause mortality.
- Incidence of ProteinuriaDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of proteinuria from Day 0.
- Incidence of Zoonotic InfectionDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of zoonotic infection from Day 0.
- Incidence of Opportunistic InfectionDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of opportunistic infection from Day 0.