StudyFinder
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
RECRUITING
18 years to 74 years old
Key
Inclusion Criteria:
* MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria.
* Biopsy must be prior to randomization.
* For participants who received any prior treatment for antibody-mediated rejection (AMR) or MVI, the biopsy must be performed after completing (or stopping) prior treatment.
* Kidney transplant prior to Screening visit (recipients of either living or deceased donors).
Key Exclusion Criteria:
* Transplant: Blood type (ABO)-incompatible transplant.
* History of multiple organ transplants including en bloc and dual kidney transplants.
* Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.DRUG: Felzartamab, DRUG: Placebo
Microvascular Inflammation
Kidney Transplant, Kidney Transplant Rejection
US Biogen Clinical Trial Center - clinicaltrials@biogen.com
NCT07219043