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New hope for kidney transplant patients: extended drug trial targets rejection

NCT ID NCT07444489

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This study offers kidney transplant patients with antibody-mediated rejection (AMR) the chance to receive felzartamab for up to 4 more years. AMR occurs when the immune system attacks the new kidney. The main goal is to check long-term safety and monitor kidney health through biopsies and lab tests. Participants who already received felzartamab in a prior study can join, while those who stopped the drug will only be monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 201 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Participants who discontinued study treatment prior to receiving any doses of felzartamab in the parent study (i.e., those in the placebo group who discontinued before receiving felzartamab) are not eligible for enrollment in this substudy. * 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. Key Exclusion Criteria: * 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). Note: Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

acute transplant rejection endotheliitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibody-mediated rejection Microvascular inflammation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • California Pacific Medical Center (Sutter Health)

    San Francisco, California, 94115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cooperman Barnabas Medical Center

    West Orange, New Jersey, 07039, United States

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Penn Medicine - Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UCLA College of Medicine

    Los Angeles, California, 90095, United States

  • University of Nebraska Medical Center (UNMC) - Nebraska Medicine - Nebraska Medical Center

    Omaha, Nebraska, 68198-3040, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.