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Pig Kidney Transplant for Kidney Failure
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are between 18 and 75 years old.You are younger than 18 years old or older than 76 years old.Your body mass index (BMI) is too low (less than 18) or too high (more than 41).You have serious health problems like uncontrolled high blood pressure or diabetes, advanced heart disease, or no suitable options for surgery.You have significant emotional or mental health challenges and/or lack strong support from family and friends.You are currently using illegal drugs or drinking alcohol excessively.You have been hospitalized for mental health reasons in the past.Having a transplant before it's needed.Your body mass index (BMI) is between 18 and 40.You have factors that make it more likely for you to have a higher risk of not getting an organ, or you might have to wait a long time for an organ, or you might not be able to get an organ when it's offered to you.You have a mental health condition that has not been treated.You have specific factors that may make it difficult to find a suitable organ for transplantation, such as high cPRA (a measure of antibody levels) or previous transplant complications.You have a condition that makes your blood more likely to form clots.You cannot tolerate medication that weakens your immune system.You have a history of not following medical advice or treatment.You are on the waiting list for a kidney transplant at UAB.You need to have regular dialysis treatment.You have a high chance of not surviving while waiting for an organ, or you might have to wait a long time for an organ, or you might not be able to get a suitable organ offer.Your body's compatibility with a pig donor has been tested and approved.You have received the COVID-19 vaccine as per the latest CDC recommendations.
- Group 1: Porcine Kidney (UKidney) transplant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
Is age 55 a cutoff for qualification in this medical trial?
"This medical study is looking for participants aged 18-75."
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."
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."
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"
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