Study Stopped
Approval to move forward with this clinical trial has not been granted by governing bodies.
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2024
Longer than P75 for phase_1
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
January 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
February 1, 2024
January 1, 2024
4.4 years
February 27, 2022
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (55)
Patient Survival After Porcine Transplant
These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing)
30 days
Patient Survival After Porcine Transplant
These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing)
90 days
Patient Survival After Porcine Transplant
These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing)
6 months
Patient Survival After Porcine Transplant
These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing)
12 months
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Post-op day 1
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Post-op day 2
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Post-op day 3
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Week 1
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Week 2
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 1
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 2
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 3
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 4
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 5
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 6
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 7
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 8
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 9
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 10
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 11
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death.
Month 12
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Post-op day 1
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Post-op day 2
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Post-op day 3
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Week 1
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Week 2
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 1
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 2
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 3
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 4
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 5
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 6
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 7
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 8
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 9
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 10
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 11
Prevalence of blood based chimerism after transplantation
The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease
Month 12
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Post-op day 1
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Post-op day 2
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Post-op day 3
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Week 1
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Week 2
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 1
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 2
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 3
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 4
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 5
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 6
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 7
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 8
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 9
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 10
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 11
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation.
Month 12
Secondary Outcomes (13)
Kidney outcomes including:
Through study completion, an average of 1 year
Kidney outcomes including:
Through study completion, an average of 1 year
Kidney outcomes including:
Through study completion, an average of 1 year
Kidney outcomes including:
Through study completion, an average of 1 year
Kidney outcomes including:
Through study completion, an average of 1 year
- +8 more secondary outcomes
Study Arms (1)
Porcine Kidney (UKidney) transplant
EXPERIMENTALIn this phase I single arm study patients with acute renal failure will be transplanted with a porcine xenograft versus a human allograft-after transplantation the best practice standard of care will be followed for monitoring and immunosuppression with the exception of additional monitoring for potential porcine transmitted infections
Interventions
The intended clinical product is a kidney derived from a domestic pig that contains an intentional genomic alteration (IGA) to protect it after transplantation from the human immune response via inactivation of endogenous porcine genes responsible for expression of pig epitopes and inclusion of human transgenes to inhibit host immunogenic response.
Eligibility Criteria
You may qualify if:
- Ages 18-75 years
- Body mass index (BMI) 18-40 kg/m2
- Waitlisted for kidney allotransplantation at UAB
- Dialysis dependent
- Proficient in the English language
- Presence of risk factors for
- high wait list mortality, AND/OR
- anticipated or actual prolonged wait time on the wait list, AND/OR
- inability to access a suitable organ offer.
- Note: Examples of risk factors include high cPRA, frequent incompatible crossmatches leading to prolonged wait times, listing at an advanced age, and impending loss of dialysis access, recurrent disease in previous transplants.
- Crossmatch compatible with porcine donor
- SARS-CoV-2 vaccination in accordance with most recent CDC guidance
- Willingness to obtain other standard-of-care vaccinations for kidney transplant recipients (MMR, HBV, Herpes Zoster, etc.) and for patients receiving eculizumab (Menactra® and Bexsero®)
- Reside within a 60-minute radius of the UAB hospital (by ground transport)
You may not qualify if:
- Age \<18y or ≥ 76y
- BMI ≤ 18 or ≥ 41 kg/m2
- Current pregnancy
- Presence of severe comorbid disease, including but not limited to uncontrolled HTN or DM (hemoglobin A1C (HgA1C) \>10%), advanced cardiovascular disease, absent surgical targets for implantation, etc.
- Presence of hypercoagulable disorder
- Inability to accept a blood transfusion
- Intolerance of immunosuppression
- History of medical non-compliance
- Presence of untreated psychiatric disease
- Significant psychosocial vulnerability and/or poor social support
- Current use/abuse of illicit drugs and/or abuse of alcohol
- History of psychiatric hospitalization
- Inability to provide informed consent
- Pre-emptive transplant
- Inability to comply with study protocols and procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- United Therapeuticscollaborator
- Lung Biotechnology PBCcollaborator
Study Sites (1)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (1)
Bobier C, Reinhardt N, Pawlowski K. Animal rights, animal research, and the need to reimagine science. New Bioeth. 2024 Mar;30(1):63-76. doi: 10.1080/20502877.2023.2300232. Epub 2024 Jan 5.
PMID: 38182130DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayme E Locke, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2022
First Posted
April 22, 2022
Study Start
January 31, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
February 1, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share