What side effects are associated with this type of intervention?

Common treatments for chronic kidney failure, such as dialysis and kidney transplantation, often involve immunosuppressive medications to prevent organ rejection. These medications can cause side effects including increased risk of infections, gastrointestinal issues, cardiovascular complications, and potential nephrotoxicity. In the context of porcine kidney xenotransplantation, additional risks include zoonotic disease transmission and acute vascular rejection.

What prior FDA approvals exist?

FDA approvals for the treatment of Chronic Kidney Failure have included various immunosuppressive therapies to prevent graft rejection in kidney transplantation. Notable drugs include tacrolimus and cyclosporine, which are calcineurin inhibitors used to suppress the immune response. Additionally, mycophenolate mofetil and azathioprine are antimetabolites that inhibit lymphocyte proliferation. While these treatments do not involve genetic modifications like the Porcine Kidney Xenotransplantation trial, they are crucial in managing the immune response to prevent graft rejection.

What other types of research exist?

Promising alternatives to porcine kidney xenotransplantation for chronic kidney failure patients include: 1) Transplantation of kidneys from hepatitis C-infected donors to hepatitis C-negative recipients, which has shown success with direct-acting antiviral prophylaxis. 2) Advanced immunosuppressive therapies, such as the use of monoclonal antibodies (e.g., basiliximab, alemtuzumab) and optimized dosing of thymoglobulin. 3) Stem cell therapy and regenerative medicine approaches, which are being explored to repair or replace damaged kidney tissue. 4) Bioengineered organs, which involve creating functional kidney tissues using 3D printing and other tissue engineering techniques.

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Xenotransplantation

Pig Kidney Transplant for Kidney Failure

Q: What is the mechanism of action of this treatment?

Common treatments for chronic kidney failure include dialysis, kidney transplantation, and emerging therapies like xenotransplantation. Dialysis works by mechanically filtering waste products and excess fluids from the blood, mimicking kidney function. Kidney transplantation involves replacing the failed kidney with a healthy donor kidney, restoring normal kidney function. Xenotransplantation, such as the use of genetically modified pigs with 10 gene edits, aims to reduce immunologic harm and rejection by the recipient's immune system. This is crucial for chronic kidney failure patients as it offers a potential solution to the organ shortage crisis, providing a sustainable and effective treatment option that can improve survival and quality of life.

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

Must not have

Age <18y or ≥ 76y

Presence of hypercoagulable disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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You have a condition that makes your blood more likely to form clots.

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You cannot tolerate medication that weakens your immune system.

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You have a mental health condition that has not been treated.

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Having a transplant before it's needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of one year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Isoantibodies

Patient Survival After Porcine Transplant

Transplantation

+1 more

Secondary study objectives

Cardiovascular outcomes including

Histologic outcomes including

Immunologic outcomes

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic kidney failure include dialysis, kidney transplantation, and emerging therapies like xenotransplantation. Dialysis works by mechanically filtering waste products and excess fluids from the blood, mimicking kidney function. Kidney transplantation involves replacing the failed kidney with a healthy donor kidney, restoring normal kidney function. Xenotransplantation, such as the use of genetically modified pigs with 10 gene edits, aims to reduce immunologic harm and rejection by the recipient's immune system. This is crucial for chronic kidney failure patients as it offers a potential solution to the organ shortage crisis, providing a sustainable and effective treatment option that can improve survival and quality of life.

A systematic review and meta-analysis of cell-based interventions in experimental diabetic kidney disease.Alkali supplementation as a therapeutic in chronic kidney disease: what mediates protection?Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis.