Status:
NOT_YET_RECRUITING
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Lead Sponsor:
Biogen
Conditions:
Microvascular Inflammation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI ...
Detailed Description
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with complement activation (C4d)-positive or C4d-negative do...
Eligibility Criteria
Inclusion
- Key
- C4d-positive or C4d-negative DSA-negative MVI (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria.
- Biopsy must be within 3 months (preferably within 1 month) prior to randomization.
- a. For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or stopping) prior treatment.
- Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
- DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization.
- Key
Exclusion
- Transplant: Blood type (ABO)-incompatible transplant.
- History of multiple organ transplants including en bloc and dual kidney transplants.
- Presence of HLA donor-specific antibodies.
- 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.
- Prior AMR or 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 DSA-negative MVI and to determine eligibility:
- Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
- Complement system inhibitors (e.g., eculizumab).
- Proteasome inhibitors (e.g., bortezomib).
- Tocilizumab.
- Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2028
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07219043
Start Date
December 1 2025
End Date
February 10 2028
Last Update
November 24 2025
Active Locations (1)
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1
Cooperman Barnabas Medical Center
West Orange, New Jersey, United States, 07039