Purpose of this Study
We are doing this study to find out if an experimental drug called efgartigimod (the study drug) is a safe and effective option for people experiencing kidney rejection. We want to know if it can decrease antibody-mediated rejection following a transplant by removing the antibodies that target and damage the cells of the donated kidney.
Who Can Participate?
Eligibility
Adults ages 18-80 who:
- Received a kidney transplant at least 6 months ago
- Are diagnosed with biopsy-confirmed antibody-mediated rejection
- Are using an immunosuppressing medication for maintenance following their transplant
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 groups. Depending on your group assignment, you may:
- Take the study drug for 48 weeks; OR
- Take a placebo (inactive substance with no drug in it) for 48 weeks; OR
- Take a combination of the study drug (first 24 weeks) and a placebo (second 24 weeks)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled,
Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of
Efgartigimod in Kidney Transplant Recipients With
Antibody-Mediated Rejection
Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of
Efgartigimod in Kidney Transplant Recipients With
Antibody-Mediated Rejection
Principal Investigator
Goni
Katz-Greenberg
Protocol Number
PRO00116061
NCT ID
NCT06503731
Phase
II
Enrollment Status
Open to Enrollment