Purpose of this Study
After the screening, the study will last up to one year and has two parts. People in the study will be randomly placed into two groups. In Part A, one group will get the study medicine, and the other group will get a placebo, which looks like the medicine but does not do anything. In Part B, everyone will get the study medicine. The medicine or placebo will be given through a tube into a vein in the arm. During the study, everyone will have checkups, give blood samples, have kidney tissue samples taken (called biopsies), and answer questions about how they feel.
Who Can Participate?
Eligibility
To join this study, people must be between 18 and 75 years old and have a kidney problem called microvascular inflammation confirmed by a biopsy. They need to be taking regular medicine to protect their transplant and cannot have had more than one organ transplant. They also cannot have active tuberculosis, hepatitis, or a history of HIV.
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
This study wants to learn if a medicine called felzartamab is safe and works well. It will also look at how the medicine moves through the body and how it affects the immune system, which helps protect you from sickness.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI) - (TRANSPIRE)
Principal Investigator
Scott
Sanoff
Protocol Number
PRO00119082
Phase
III
Enrollment Status
Pending Open to Enrollment