NCT06685757
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
Active, Not Recruiting
PHASE3Ages 18–75InterventionalTreatmentBiogen
~132 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:FelzartamabPlacebo
At a glance
Recruiting sites
0 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Measured over Week 24
Conditions
Where it's being run
56 sites across 36 statesCalifornia7
France4
Germany4
Ohio3
Barcelona3
Texas2
Australia2
São Paulo2
Study leadership
- Medical Director · STUDY_DIRECTOR · Biogen
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization.
Exclusion
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 subsequent 30 days as determined by the Investigator.
Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility:
What this trial measures
- Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)Week 24