Back to search results

Felzartamab for Late Isolated Microvascular Inflammation in Kidney Transplant Patients

This study is looking into felzartamab infusions for adults who have received a kidney transplant and later developed microvascular inflammation (MVI). MVI is an injury to tiny blood vessels in the transplanted kidney, which can be a sign of the body rejecting the kidney and may lead to serious kidney problems. This study focuses on a specific type of MVI called isolated MVI, where antibodies are not the cause. Currently, there are no approved treatments for isolated MVI. You may be able to join if you are between 18 and 74 years old and have biopsy-confirmed MVI without T cell-mediated rejection. The main goal is to see if felzartamab helps reduce this inflammation in the transplanted kidney. The study is currently recruiting 81 participants.

Study design
This interventional study will compare felzartamab to a placebo in 81 participants. It is not specified if participants or researchers will know which treatment is being given.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for Part A of the study is measured at Week 24. Efficacy of felzartamab will be summarized up to Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219043

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

Recruiting
PHASE2Ages 18–74InterventionalTreatment
Biogen
~81 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:FelzartamabPlacebo

At a glance

Recruiting sites
43 of 43 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

Microvascular Inflammation

Explore related trials

Kidney TransplantationPerivascular inflammation

Where it's being run

43 sites across 28 states
California6
France4
Spain4
Germany3
Ohio2
Texas2
Kansas1
Michigan1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

US Biogen Clinical Trial Center
[email protected]
866-633-4636
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
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.

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 MVI≥2 and DSA negative status and to determine eligibility:

What this trial measures

  • Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)Week 24