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10 GE Xenokidney

Phase 1

ESRD (End-Stage Renal Disease) | Monoclonal antibody | Nephrology |United Therapeutics Corporation|Last Updated: Mar 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06878560Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRDPHASE1 RECRUITING 50Oct 29, 2025Oct 1, 2075Mar 27, 20262 United States
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Study Endpoints
Primary Endpoints
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

Participant survival rate at 24 weeks post transplant.

Survival Rate of the 10 GE Xenokidney at 24 Weeks Post Transplant
Day 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 Xenokidney
Day 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 Proteinuria
Day 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 Infection
Day 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 Infection
Day 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.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
10 GE XenokidneyEXPERIMENTALParticipants will receive 10 GE Xenokidney
Interventions
NameTypeDescription
10 GE XenokidneyBIOLOGICALPorcine-derived kidney containing intentional genomic alterations for xenotransplantation
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Eligibility Criteria
Age Range40 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria for all Participants (Groups 1 and 2): 1. Provide voluntarily informed consent to participate in the study and for lifetime follow up. 2. Have a diagnosis of ESRD at the time of informed consent. 3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial v...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06878560primaryCompletionDate: changed
LOWMay 24, 2026NCT06878560studyFirstPostDate: changed