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Evaluating Felzartamab for Kidney Transplant Recipients with Antibody-Mediated Rejection

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

Phase 3 Interventional Biogen · NCT06685757

This study is testing if a new drug called felzartamab can help kidney transplant recipients with a specific type of rejection feel better and improve their kidney function compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionseculizumab, Tocilizumab, rituximab, felzartamab
Locations59 sites (Los Angeles, California and 58 other locations)
Trial IDNCT06685757 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the effectiveness of felzartamab compared to a placebo in kidney transplant recipients who are experiencing late active or chronic active antibody-mediated rejection (AMR). Participants must have a biopsy-confirmed diagnosis of AMR and have received their kidney transplant at least six months prior to the screening visit. The study will involve administering either felzartamab or a placebo to evaluate improvements in kidney function and rejection rates.

Who should consider this trial

Good fit: Ideal candidates are kidney transplant recipients with biopsy-confirmed late active or chronic active AMR and specific donor-specific antibodies.

Not a fit: Patients with blood type incompatible transplants or those who have had prior AMR treatment within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for kidney transplant recipients suffering from AMR.

How similar studies have performed: Previous studies have shown promise in treating AMR with similar approaches, but this specific treatment is being evaluated in a novel context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

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 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:

  1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
  2. Complement system inhibitors (e.g., eculizumab).
  3. Proteasome inhibitors (e.g., bortezomib).
  4. Tocilizumab.
  5. Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] agents \[e.g., rituximab\]) within 3 months prior to randomization.
  6. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Los Angeles, California and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Antibody-mediated RejectionAMRFelzartamabKidney Transplant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.