Purpose of this Study
People in this study will receive medicines to help prevent infections after a kidney transplant. They will be placed into one of two groups by chance. One group will receive a study medicine called frexalimab, while the other group will receive tacrolimus, a standard anti rejection medicine.
Frexalimab is given right after the transplant, then again two weeks later, four weeks later, and every four weeks after that for up to five years. Participants will have regular blood tests, urine tests, physical exams, heart tests, questionnaires, and kidney biopsies to monitor their health and the transplanted kidney. Some activities, such as interviews and physical activity tracking, are optional.
Researchers want to learn if frexalimab is a safe and effective alternative to tacrolimus for preventing kidney transplant rejection.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and are planning to receive their first kidney transplant from a living or deceased donor.
People cannot join if they have certain active or hidden infections, such as shingles, tuberculosis, Epstein Barr virus, HIV, or other serious infections. They also cannot join if they have cancer. Researchers are comparing a new anti rejection medicine called frexalimab with the standard medicine tacrolimus in people receiving a kidney transplant.
Age Range
18-110
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 compares a new medicine called frexalimab with a standard anti rejection medicine called tacrolimus in people who have recently received a kidney transplant. Researchers want to learn if frexalimab is safe and works as well as or better than tacrolimus at helping the body accept the new kidney and prevent transplant rejection. The goal is to find better ways to protect transplanted kidneys and improve long term health after kidney transplant surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients - FREXERA
Principal Investigator
Kadiyala
Ravindra
Protocol Number
PRO00119646
Phase
II/III
Enrollment Status
Pending Open to Enrollment