EXPAND: Safety and Efficacy of the 10 GE Xenokidney

Purpose of this Study

The study begins with a long screening period that can last up to one year. During this time, doctors will do tests to see if a person can join. If they qualify, they will go through a transplant process that may include treatments before the transplant and a hospital stay. After the transplant, recovery time can vary, but it may take one month or longer. Participants will have many follow up visits, starting with twice a week for three months, then once a week for three months, and then once a month for up to one year. The study continues for as long as the participant is alive, so doctors can learn about long term outcomes.

Who Can Participate?

Eligibility

People can join this study if they are adults who need a kidney transplant and have a high chance of dying without one within five years, or if they have a very high level of antibodies that makes it very hard to find a donor kidney. They must also have a body weight level within a certain range based on BMI. People cannot join if they have serious health problems that could make the transplant unsafe. These can include severe blood vessel disease, serious heart problems, lung disease, uncontrolled diabetes, or high blood pressure in the lungs. They also cannot join if they have certain infections such as hepatitis or HIV, a history of tuberculosis, a non kidney cause of anemia, or major mental health conditions that required hospitalization.

Age Range

40-70

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

This study is testing a new type of kidney transplant using a kidney from a genetically modified pig. The study is for people who have very serious kidney failure. Researchers want to see if this type of transplant is safe and if it can work well in humans. The goal is to learn if pig kidneys can help treat people who need a kidney transplant.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

Yes

Study Details

Full Title

EXPAND: A Prospective Study to Evaluate the Safety and Efficacy
of the 10 GE Xenokidney in Patients with End-stAge ReNal Disease
(ESRD)

Principal Investigator

Stuart
Knechtle

Protocol Number

PRO00119478

Phase

I/II

Enrollment Status

Pending Open to Enrollment