Pig Kidney Transplant for Kidney Failure

Recruiting in Palo Alto (17 mi)

Overseen byJayme E Locke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves transplanting kidneys from genetically modified pigs into patients with end-stage kidney disease. The pig kidneys are altered to be less likely rejected by the human body, and patients will take medications to suppress their immune system. Pig kidneys have been used in studies with animals, showing promise for future clinical trials.

Eligibility Criteria

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.

Inclusion Criteria

You are between 18 and 75 years old.

Reside within a 60-minute radius of the UAB hospital (by ground transport)

Your body mass index (BMI) is between 18 and 40.

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Exclusion Criteria

Inability to accept a blood transfusion

You are younger than 18 years old or older than 76 years old.

Current pregnancy

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Treatment Details

Interventions

Porcine Kidney Xenotransplantation (Xenotransplantation)

Trial OverviewThe 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.

Participant Groups

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