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Xenotransplantation

Pig Kidney Transplant for Kidney Failure

Phase 1
Waitlist Available
Led By Jayme E Locke, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-75 years
Waitlisted for kidney allotransplantation at UAB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial aims to test the safety of using genetically modified pig organs for transplantation into humans. The goal is to help solve the organ shortage crisis by expanding the organ supply in a sustainable way.

Who is the study for?
This trial is for adults aged 18-75 with end-stage kidney disease who are on dialysis, listed for a kidney transplant at UAB, and live within an hour of the hospital. They must be willing to get standard vaccinations and have factors like high waitlist mortality risk or long wait times. Pregnant individuals, those with severe diseases or psychiatric conditions, drug/alcohol abusers, and anyone unable to follow the study plan cannot join.Check my eligibility
What is being tested?
The trial tests xenotransplantation using kidneys from genetically modified pigs (10 gene edits) in people with severe kidney failure. It aims to increase organ availability by assessing patient safety over five years plus one year of follow-up after surgery. The focus is on survival rates and checking if patients catch any diseases from pig organs.See study design
What are the potential side effects?
Potential side effects may include immune reactions against the pig kidney, infections due to zoonotic transmission (diseases passed from animals to humans), complications related to surgery and anesthesia, as well as issues arising from long-term immunosuppression needed to prevent organ rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 75 years old.
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You are on the waiting list for a kidney transplant at UAB.
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You need to have regular dialysis treatment.
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Your body's compatibility with a pig donor has been tested and approved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Isoantibodies
Patient Survival After Porcine Transplant
Transplantation
+1 more
Secondary outcome measures
Cardiovascular outcomes including
Histologic outcomes including
Immunologic outcomes
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Porcine Kidney (UKidney) transplantExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,029 Total Patients Enrolled
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,387 Total Patients Enrolled
Lung Biotechnology PBCIndustry Sponsor
13 Previous Clinical Trials
711 Total Patients Enrolled

Media Library

Porcine Kidney Xenotransplantation (Xenotransplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05340426 — Phase 1
Chronic Kidney Failure Research Study Groups: Porcine Kidney (UKidney) transplant
Chronic Kidney Failure Clinical Trial 2023: Porcine Kidney Xenotransplantation Highlights & Side Effects. Trial Name: NCT05340426 — Phase 1
Porcine Kidney Xenotransplantation (Xenotransplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05340426 — Phase 1
Chronic Kidney Failure Patient Testimony for trial: Trial Name: NCT05340426 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary goals are the researchers hoping to achieve with this trial?

"With the primary goal of assessing Prevalence of blood based chimerism after transplantation over a 12 month period, this trial will also evaluate Kidney outcomes such as incidence of Primary Non-Function and Creatinine Clearance; Histologic outcomes including Acute Cellular Rejection, Antibody-Mediated Rejection and Complement Deposition; Infectious Outcomes like Surgical Site Infections and Hospital Acquired Infection; and prevalence of Conventional Opportunistic infections."

Answered by AI

Is age 55 a cutoff for qualification in this medical trial?

"This medical study is looking for participants aged 18-75."

Answered by AI

Are there any available openings for individuals seeking treatment through this trial?

"Unfortunately, the clinicaltrial.gov portal points out that this trial is no longer recruiting patients, having been originally posted on January 1st 2023 and last edited on August 30th 2022. Nonetheless, there are 676 other medical trials actively enrolling participants right now."

Answered by AI

Has UKidney earned clearance from the Federal Drug Administration?

"Data supporting UKidney's safety and effectiveness is scarce, thus it received an assessment score of 1."

Answered by AI

Could I be a prospective candidate for this medical trial?

"This trial is recruiting 20 individuals aged 18-75 suffering from chronic renal failure who meet the following criteria: Body Mass Index (BMI) between 18 and 40 kg/m2, possess a proficient command of English language, demonstrate risk factors for high wait list mortality OR anticipated or actual extended wait time on the waiting list OR lack access to an appropriate organ offer, compatible with porcine donor SARS-CoV-2 vaccination in accordance with most recent CDC guidance, willing to receive other standard vaccinations such as MMR, HBV or Herpes Zoster etc., reside 60 minutes away from UAB hospital by road transport and be wait"

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Alabama Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Kentucky
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Dialysis patient looking for help for my father.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
~0 spots leftby Jun 2028