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Long-Term Study of Felzartamab for Kidney Transplant Rejection

This study is looking at the long-term safety and effects of felzartamab infusions in adults who have received a kidney transplant. Participants in this study have developed either antibody-mediated rejection (AMR), where the body's immune system attacks the transplanted kidney, or microvascular inflammation (MVI), which is inflammation of the small blood vessels in the transplanted kidney. Both AMR and MVI can cause the transplanted kidney to not work well. This study aims to understand how safe felzartamab is over time and how well it continues to help with these conditions. Researchers will be tracking side effects and how the kidney is functioning. You may be able to join if you are between 18 and 75 years old and have already participated in a previous study of felzartamab for these conditions.

Study design
This is an interventional study with a planned enrollment of 201 participants. It is a long-term follow-up to previous studies of felzartamab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and other effects from their first dose of felzartamab up to the end of the study follow-up, which could be up to Week 204.

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

NCT07444489

A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)

Enrolling by Invitation
PHASE3Ages 18–75InterventionalTreatment
Biogen
~201 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Felzartamab

At a glance

Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Measured over From first dose of study drug up to end of study follow-up (Up to Week 204)
+2 more outcomes measured

Conditions

Antibody-mediated Rejection
Microvascular Inflammation

Explore related trials

Acute Allograft NephropathyHyperacute graft rejectionPerivascular inflammation

Where it's being run

12 sites across 9 states
California3
Ohio2
Minnesota1
Nebraska1
New Jersey1
Pennsylvania1
Virginia1
Washington1

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

Have completed the parent study Week 52 visit or will be completing Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit).
Have received at least one dose of felzartamab in the parent studies, and had the following disposition status in the parent study:
Ongoing Treatment: Did not discontinue felzartamab treatment in the parent study and received a dose at the Week 44 visit.
Treatment Interrupted: Did not discontinue felzartamab treatment in the parent study and did not receive a dose at the Week 44 visit.
Off Treatment, On Study: Discontinued felzartamab treatment in the parent study and were not withdrawn from the study.
For participants enrolling into this study who have not discontinued felzartamab treatment in the parent study only: The Investigator has determined that the participant could benefit from continued felzartamab treatment.

Exclusion

Met a treatment discontinuation criterion in the parent study but treatment was not discontinued (for example, because the criterion was met after the last dose of felzartamab in the parent study).

What this trial measures

  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)From first dose of study drug up to end of study follow-up (Up to Week 204)
  • Number of Participants who Discontinue Treatment due to an AEFrom first dose of study drug up to end of study follow-up (Up to Week 204)
  • Number of Participants with Clinically Significant Laboratory, Vital Signs and Electrocardiograms (ECGs) AbnormalitiesFrom first dose of study drug up to end of trial visit (up to Week 200)