GGTA1 KO Thymokidney for Kidney Failure
(EXTEND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for kidney failure using a special type of kidney called the GGTA1 KO Thymokidney. The main goal is to determine if this treatment is safe and effective for individuals with end-stage kidney disease who cannot receive a regular kidney transplant or are unlikely to receive one in time. The process involves xenotransplantation, where an organ from another species is used. The study seeks participants who have been on dialysis for at least six months and have a working dialysis access, such as a fistula or catheter. It is suitable for those living near the transplant center and who have specific medical conditions that make regular transplants not an option. As a Phase 1, Phase 2 trial, this study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you cannot stop taking chronic anticoagulation therapy (except low-dose aspirin).
What prior data suggests that the GGTA1 KO Thymokidney is safe for patients with end-stage renal disease?
Research has shown that the GGTA1 KO Thymokidney is still undergoing safety testing in humans. Limited data is available, but it is important to note that this treatment remains in the early testing stages. Researchers are primarily focused on assessing patient tolerance and identifying any side effects. Because it involves xenotransplantation, or transplanting animal organs into humans, scientists closely monitor for unusual immune reactions or infections. Although this process appears promising, participants should stay informed and discuss potential risks with their doctors.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for kidney failure, which often involve dialysis or kidney transplants, the GGTA1 KO Thymokidney is a bioengineered organ that could potentially eliminate the need for donor kidneys and long waiting lists. This innovative treatment involves genetically modifying a thymokidney to be more compatible with human immune systems, reducing the risk of rejection. Researchers are excited because this approach could revolutionize kidney transplantation by providing a more sustainable and readily available solution for patients with kidney failure.
What evidence suggests that the GGTA1 KO Thymokidney might be an effective treatment for end-stage renal disease?
Research has shown that the GGTA1 KO Thymokidney is designed to help people with end-stage renal disease (ESRD). This treatment involves xenotransplantation, using a kidney from another species that has been genetically modified to reduce the chance of rejection by the human immune system. Studies have found that people with ESRD have lower levels of antibodies that usually attack foreign tissues, making them good candidates for receiving organs like the GGTA1 KO Thymokidney. Early results suggest that the GGTA1 KO Thymokidney could be a new option for those unlikely to receive a traditional kidney transplant.12367
Are You a Good Fit for This Trial?
This trial is for patients with end-stage renal disease (ESRD) who can't have standard kidney transplants or are unlikely to receive one from the waitlist within 5 years. Participants will be monitored long-term for survival, organ function, and infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Xenotransplantation
Participants receive the GGTA1 KO Thymokidney transplantation
Post-transplant Follow-up
Evaluation of efficacy and safety objectives, including all study endpoints and safety assessments
Long-term Follow-up
Evaluation of participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections
What Are the Treatments Tested in This Trial?
Interventions
- GGTA1 KO Thymokidney
Trial Overview
The study tests a genetically-engineered pig kidney transplant called GGTA1 KO Thymokidney in two groups of ESRD patients. It includes initial follow-up for safety and efficacy, then lifetime monitoring for those with successful transplants.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive GGTA1 KO Thymokidney
Find a Clinic Near You
Who Is Running the Clinical Trial?
United Therapeutics
Lead Sponsor
Dr. Martine Rothblatt
United Therapeutics
Chief Executive Officer since 1996
PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA
Dr. Michael Benkowitz
United Therapeutics
Chief Medical Officer since 2023
MD from Harvard Medical School
Citations
Study to Evaluate the Safety and Efficacy of the GGTA1 KO ...
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) ...
GGTA1 KO Thymokidney for Kidney Failure (EXTEND Trial)
... efficacy for patients with Kidney Failure, Kidney Transplant, Animal-to-human organ transplant, Chronic Kidney Disease and Chronic Renal Failure. See if you ...
3.
ctv.veeva.com
ctv.veeva.com/study/study-to-evaluate-the-safety-and-efficacy-of-the-ggta1-ko-thymokidney-in-patients-with-esrdStudy to Evaluate the Safety and Efficacy of the GGTA1 KO ...
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) ...
PERSPECTIVES ON THE OPTIMAL GENETICALLY ...
Antibodies to Gal and Neu5Gc are particularly low in patients with end-stage renal disease undergoing regular hemodialysis (Figure 3), as is antibody binding to ...
GGTA1 KO Thymokidney in Kidney Transplantation and ...
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) ...
GGTA1 KO Thymokidney in Kidney Transplantation and ESRD (End ...
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either ...
The Resurgence of Xenotransplantation - Cowan - 2017
Humoral reactivity of renal transplant-waitlisted patients to cells from GGTA1/CMAH/B4GalNT2, and SLA Class I knockout pigs. Transplantation ...
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