Felzartamab infusions for adults with kidney transplants and late isolated microvascular inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled study (Part A) comparing felzartamab to placebo in kidney transplant recipients with biopsy-confirmed late isolated microvascular inflammation (MVI ≥2) who are donor-specific antibody (DSA) negative. Eligible participants must have an adequate recent biopsy (preferably within 1 month, no more than 3 months) and be at least 6 months post-transplant; Cohort 1 is evaluated at Week 24 with follow-up through Week 52 across Cohorts 1 and 2. Primary outcome is the proportion of participants without signs of active inflammation in the transplanted kidney at 24 weeks; secondary outcomes include kidney function, immune activity, safety, pharmacokinetics, and immunogenicity. The trial is sponsored by Biogen and is being run at three clinical sites in California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting
• Keck Hispital of University of Southern California (USC)
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Providence St. Joseph Hospital Orange
  Orange, California, United States Recruiting
• Sutter Health - California Pacific Medical Center
  San Francisco, California, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.