ESRD (End-Stage Renal Disease)Phase 1/2EXPANDNCT06878560
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
A Phase 1/2 study testing 10 GE Xenokidney in people with ESRD (End-Stage Renal Disease) and Kidney Transplantation, run by United Therapeutics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
- What is being tested?
- 10 GE Xenokidney
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2025to Oct 2075
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide voluntarily informed consent to participate in the study and for lifetime follow up.
- Have a diagnosis of ESRD at the time of informed consent.
- Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula/graft or permanent catheter at the time of informed consent.
- 50 to 70 years of age at the time of informed consent, or 40 to <50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%.
- Live withing 3 hours travel time of the xenotransplant center.
- Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.
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- Negative xeno-crossmatch at Screening and pre-transplant.
- Estimated Post Transplant Survival Calculator score >20% (https://optn.transplant.hrsa.gov/data/allocation-calculators/epts-calculator/).
- Body mass index ≤35 kg/m2.
- Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention recommended courses of age and risk factor appropriate vaccinations.
- Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.
- Additional Inclusion Criteria for Group 1:
- 1. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:
- Ineligible for a living donor transplant.
- Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).
- Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).
- Additional Inclusion Criteria for Group 2:
- On an OPTN kidney transplant waitlist (active or inactive status).
- No approved living kidney donors.
- More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for "Choose your state" field and National average for "Choose your transplant program" field; https://www.srtr.org/tools/kidney-transplant-decision-aid/).
- Exclusion Criteria (pertain to all participants in Groups 1 and 2):
- Need for multiple organ transplants.
- Severe medical co-morbidities including, but not limited to:
- Chronic liver disease.
- Advanced cardiovascular disease.
- Severe peripheral vascular disease that limits technical ability to transplant the 10 GE Xenokidney.
- Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.
- Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent or continuous supplemental oxygen.
- Pulmonary hypertension.
- Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.
- Severe neurogenic bladder that requires intermittent catheterization.
- ESRD due to hereditary or structural kidney disease.
- Active or recently treated malignancy at the time of informed consent.
- Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).
- Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).
- History of major psychiatric disorders with a psychiatric hospitalization and/or suicidal ideation within 5 years of informed consent.
- Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.
- Nucleic acid test (NAT) positive for hepatitis B virus and/or hepatitis C virus, hepatitis B surface antibody (anti HBs) titer <10 mIU/mL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HBs titer <10 mIU/mL after having completed both the standard vaccine series and a fourth booster dose and/or second standard vaccine series), and/or positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and/or NAT).
- Not able to independently perform activities of daily life.
- Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder (SUD) within 1 year of informed consent, lack of social support, untreated psychological conditions).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Michelle Callegari, michelle.callegari@northwestern.edu
Satish N Nadig, MD, PhD, FACS
- Recruiting
New York University Langone Health
New York, New York, 10016
Karen Khalil, 347-514-2758, karen.khalil@nyulangone.org
Robert A Montgomery, MD, DPhil
About this study
Official title: EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (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 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.
Read the detailed description
This is a Phase 1/2/3, multicenter, open-label, safety and efficacy study of the 10 GE Xenokidney in patients with ESRD. The study will be comprised of the following:
- A Screening Period up to 52 weeks.
- Part A consists of the 10 GE Xenokidney transplantation followed by a 24-week Post-transplant Follow-up Period, including the evaluation of all study endpoints and safety assessments.
- Part B is a Long-term Follow-up Period that extends for the lifetime of participants who received the 10 GE Xenokidney, including but not limited to documentation of participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections.
There will be 2 groups of participants enrolled in the study. Group 1 will be participants deemed ineligible for conventional allogeneic kidney transplantation due to medical reason(s). Group 2 will be participants on an OPTN kidney transplant waitlist but are more likely to die or go untransplanted within 5 years than receive a kidney transplant.
- Being tested
- 10 GE Xenokidney
- Keywords
- 10 GE Xenokidney, End-stage renal disease, ESRD, Xenotransplantation
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 GE XenokidneyBiological
Also called Xenokidney, UKidney
Porcine-derived kidney containing intentional genomic alterations for xenotransplantation
| Study group | Role | What they receive |
|---|---|---|
| 10 GE Xenokidney | Experimental | Participants will receive 10 GE Xenokidney Receives: Biological: 10 GE Xenokidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant
Participant survival rate at 24 weeks post transplant.
Measured: Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Rate of the 10 GE Xenokidney at 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.
Measured: Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Time of Participants Receiving the 10 GE Xenokidney
Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause
Measured: 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
Survival Time of the 10 GE Xenokidney (Overall Survival)
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.
Measured: 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
Survival Time of the 10 GE Xenokidney (Death-censored Survival)
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.
Measured: 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
10 GE Xenokidney Function Post Transplant (Endogenous GFR)
Endogenous measured GFR (24-hour urine creatinine clearance) at 24 weeks post transplant.
Measured: At 24 weeks post transplant
10 GE Xenokidney Function Post Transplant (Exogenous GFR)
Exogenous measured GFR (nuclear medicine GFR) at 24 weeks post transplant.
Measured: At 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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).
Measured: Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Standardized Outcomes in Nephrology Life Participant (SONG-LP)
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).
Measured: Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Kidney Transplant Questionnaire (KTQ)
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.
Measured: Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Patient Global Impression of Change (PGI-C)
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).
Measured: At 24 weeks post transplant
Incidence of Treatment-Emergent Adverse Events (Safety of the 10 GE Xenokidney)
Incidence of adverse events and serious adverse events; all-cause mortality.
Measured: 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 Proteinuria
Incidence of proteinuria from Day 0.
Measured: 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
Incidence of zoonotic infection from Day 0.
Measured: 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
Incidence of opportunistic infection from Day 0.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start29 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2075 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRD (End-Stage Renal Disease)Studies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single group study will enroll participants simultaneously from either of two patient populations: (1) participants that are ineligible for conventional allogeneic kidney transplantation due to medical reason or (2) participants on an Organ Procurement and Transplantation Network kidney transplant waitlist that are more likely to die or go untransplanted within 5 years than receive a kidney transplant.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878560
- Sponsor's protocol ID
- GPK-KF-101
- Acronym
- EXPAND
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT06878560
- Acronym / sponsor ID
- EXPAND / GPK-KF-101
- Keywords
- 10 GE Xenokidney, End-stage renal disease, ESRD, Xenotransplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2075 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1/2/3, multicenter, open-label, safety and efficacy study of the 10 GE Xenokidney in patients with ESRD. The study will be comprised of the following:
- A Screening Period up to 52 weeks.
- Part A consists of the 10 GE Xenokidney transplantation followed by a 24-week Post-transplant Follow-up Period, including the evaluation of all study endpoints and safety assessments.
- Part B is a Long-term Follow-up Period that extends for the lifetime of participants who received the 10 GE Xenokidney, including but not limited to documentation of participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections.
There will be 2 groups of participants enrolled in the study. Group 1 will be participants deemed ineligible for conventional allogeneic kidney transplantation due to medical reason(s). Group 2 will be participants on an OPTN kidney transplant waitlist but are more likely to die or go untransplanted within 5 years than receive a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single group study will enroll participants simultaneously from either of two patient populations: (1) participants that are ineligible for conventional allogeneic kidney transplantation due to medical reason or (2) participants on an Organ Procurement and Transplantation Network kidney transplant waitlist that are more likely to die or go untransplanted within 5 years than receive a kidney transplant.
| Arm | Type | Receives |
|---|---|---|
| 10 GE Xenokidney | Experimental | Biological: 10 GE XenokidneyParticipants will receive 10 GE Xenokidney |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Provide voluntarily informed consent to participate in the study and for lifetime follow up.
- Have a diagnosis of ESRD at the time of informed consent.
- Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula/graft or permanent catheter at the time of informed consent.
- 50 to 70 years of age at the time of informed consent, or 40 to <50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%.
- Live withing 3 hours travel time of the xenotransplant center.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 GE XenokidneyAlso: Xenokidney, UKidneyPorcine-derived kidney containing intentional genomic alterations for xenotransplantation | Biological | 10 GE Xenokidney |
Primary outcome
Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 10 GE Xenokidney in people with ESRD (End-Stage Renal Disease) and Kidney Transplantation, run by United Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact United Therapeutics Global Medical Information (919-485-8350, clinicaltrials@unither.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant (time frame: Day 0 (day of xenotransplantation) to 24 weeks post transplant). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.