Purpose of this Study
We are doing this study to find out if an experimental drug called ALXN2030 (the study drug) is a safe and effective option for people diagnosed with antibody-mediated rejection (AMR) of a transplanted kidney.
Who Can Participate?
Eligibility
Adults ages 18-75 who:
- Are diagnosed with active or chronic active AMR
- Are vaccinated against meningococcal infection, pneumonia, and influenza
Age Range
18-75
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 to either:
- Get the study drug; OR
- Get a placebo (inactive substance with no drug in it)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients with Antibody-Mediated Rejection after Kidney Transplantation
Principal Investigator
Stuart
Knechtle
Protocol Number
PRO00117477
NCT ID
NCT06744647
Phase
II
Enrollment Status
Pending Open to Enrollment