Porcine Kidney (UKidney) transplant for Kidney Failure, Chronic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama Birmingham, Birmingham, AL
Kidney Failure, Chronic+2 More
UKidney - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Kidney Failure, Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Through study completion, an average of one year

12 months
Patient Survival After Porcine Transplant
Month 12
Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney
Prevalence of blood based chimerism after transplantation
Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney
Year 1
Kidney outcomes including
Through study completion, an average of one year
Cardiovascular outcomes including
Histologic outcomes including
Immunologic outcomes
Infectious outcomes including

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Porcine Kidney (UKidney) transplant
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Porcine Kidney (UKidney) transplant · No Placebo Group · Phase 1

Porcine Kidney (UKidney) transplant
Device
Experimental Group · 1 Intervention: UKidney · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of one year

Trial Background

Prof. Jayme E Locke, Professor
Principal Investigator
University of Alabama at Birmingham
Closest Location: University of Alabama Birmingham · Birmingham, AL
Photo of university of alabama at birmingham  1Photo of university of alabama at birmingham  2Photo of university of alabama at birmingham  3
2010First Recorded Clinical Trial
1 TrialsResearching Kidney Failure, Chronic
70 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a BMI of 18-40 kg/m2.
You are proficient in the English language.
The blood product is compatible with the SARS-CoV-2 vaccine in accordance with most recent CDC guidance.
You are within a 60-minute radius of the UAB hospital.
You are waitlisted for kidney transplantation at UAB.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.