Status:
WITHDRAWN
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
United Therapeutics
Lung Biotechnology PBC
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 ...
Detailed Description
Twenty patients with ESKD listed for kidney allotransplantation at UAB will be enrolled to receive either one or two porcine kidney xenotransplants from a 10-GE pig donor, contingent on the pig's over...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05340426
Start Date
January 31 2024
End Date
June 30 2029
Last Update
February 1 2024
Active Locations (1)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294