clinicaltrials上的发布，2022年9月份开始，持续6年。
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Trial record 1 of 28 for: "Xenotransplantation" "renal"
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Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Sponsor:
University of Alabama at Birmingham
Collaborators:
United Therapeutics
Lung Biotechnology PBC
Information provided by (Responsible Party):
Jayme E Locke, University of Alabama at Birmingham
Study Description
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.
Condition or disease Intervention/treatment Phase
Kidney Failure, ChronicDevice: UKidneyPhase 1
Show Show detailed description
.......
Study Design
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :20 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Intervention Model Description:Phase I clinical trial involving the use of a porcine kidney xenograft for transplant in place of a human kidney allograft to treat chronic renal failure in patients on dialysis
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Estimated Study Start Date :September 1, 2022
Estimated Primary Completion Date :June 30, 2027
Estimated Study Completion Date :June 30, 2028
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Kidney Diseases Kidney Failure
U.S. FDA Resources
Arm
Experimental: Porcine Kidney (UKidney) transplant
In 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
Intervention/treatment
Device: UKidney
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.
Other Names:
Porcine Kidney
Xenotransplant
Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05340426
Contacts
Contact: Leigh A McManus, MSHQS205-934-2131lmcmanus@uabmc.edu
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Contact: Leigh A McManus, MSHQS 205-934-2131 lmcmanus@uabmc.edu
Principal Investigator: Jayme E Locke, MD
Sub-Investigator: Paige Porrett, MD
Sponsors and Collaborators
University of Alabama at Birmingham
United Therapeutics
Lung Biotechnology PBC
Investigators
Principal Investigator:Jayme E Locke, MDUniversity of Alabama at Birmingham
More Information
Go to sections
Responsible Party:Jayme E Locke, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:NCT05340426 History of Changes
Other Study ID Numbers:IRB-300008933
First Posted:April 22, 2022 Key Record Dates
Last Update Posted:June 2, 2022
Last Verified:June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No
HomeSearch ResultsStudy Record Detail Save this study
Trial record 1 of 28 for: "Xenotransplantation" "renal"
Previous Study | Return to List | Next Study
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Sponsor:
University of Alabama at Birmingham
Collaborators:
United Therapeutics
Lung Biotechnology PBC
Information provided by (Responsible Party):
Jayme E Locke, University of Alabama at Birmingham
Study Description
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.
Condition or disease Intervention/treatment Phase
Kidney Failure, ChronicDevice: UKidneyPhase 1
Show Show detailed description
.......
Study Design
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :20 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Intervention Model Description:Phase I clinical trial involving the use of a porcine kidney xenograft for transplant in place of a human kidney allograft to treat chronic renal failure in patients on dialysis
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Estimated Study Start Date :September 1, 2022
Estimated Primary Completion Date :June 30, 2027
Estimated Study Completion Date :June 30, 2028
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Kidney Diseases Kidney Failure
U.S. FDA Resources
Arm
Experimental: Porcine Kidney (UKidney) transplant
In 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
Intervention/treatment
Device: UKidney
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.
Other Names:
Porcine Kidney
Xenotransplant
Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05340426
Contacts
Contact: Leigh A McManus, MSHQS205-934-2131lmcmanus@uabmc.edu
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Contact: Leigh A McManus, MSHQS 205-934-2131 lmcmanus@uabmc.edu
Principal Investigator: Jayme E Locke, MD
Sub-Investigator: Paige Porrett, MD
Sponsors and Collaborators
University of Alabama at Birmingham
United Therapeutics
Lung Biotechnology PBC
Investigators
Principal Investigator:Jayme E Locke, MDUniversity of Alabama at Birmingham
More Information
Go to sections
Responsible Party:Jayme E Locke, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:NCT05340426 History of Changes
Other Study ID Numbers:IRB-300008933
First Posted:April 22, 2022 Key Record Dates
Last Update Posted:June 2, 2022
Last Verified:June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No
