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NCT07219043 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Microvascular Inflammation, sponsored by Biogen.

Recruiting
Registry status
Phase 2
Development phase
81
Enrollment target
12
Study locations

NCT07219043: Recruiting Phase 2 study of Microvascular Inflammation, sponsored by Biogen.

NCT07219043 is a Phase 2 study of Microvascular Inflammation that is actively recruiting participants, run by Biogen. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07219043, a Phase 2 study of Microvascular Inflammation, is actively recruiting participants, sponsored by Biogen.

RECRUITING
Registry status
Phase 2
Development phase
81 participants
Enrollment target
12
Study locations

Study Summary

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time. The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is: • How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab? Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study. Adverse events are unwanted health problems that may or may not be caused by the study drug. The study will be done in 2 parts as follows: * Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo. * Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this. * All treatments will be given by intravenous (IV) infusion at the study site. * Participants will have kidney biopsies at the start of the study, at week 24, and at week 52 to help measure changes in inflammation. * Participants will stay in the study for about 1 year.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Felzartamab

Study Locations (12)

California

  • Keck Hispital of University of Southern California (USC) - Los Angeles
  • Providence St. Joseph Hospital Orange - Orange
  • Sutter Health - California Pacific Medical Center - San Francisco

Ohio

  • Cleveland Clinic - Cleveland
  • The Ohio State University - Columbus

Other

  • Medizinische Universität Wien - Vienna
  • Charité - Universitätsmedizin Berlin - Berlin

Minnesota

  • Mayo Clinic Rochester - Rochester

New Jersey

  • Cooperman Barnabas Medical Center - West Orange

Washington

  • University of Washington Medical Center - Seattle

Wisconsin

  • Medical College of Wisconsin - Milwaukee

São José Do Rio Preto

  • Hospital de Base da Faculdade de Medicina de São José do Rio Preto - Vila São José

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2026-01-05
Est. Completion 2028-02-10
Phase Phase 2
Biogen

334 total trials

What NCT07219043 shows while recruiting

NCT07219043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).

The record links to 1 condition, with Microvascular Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07219043 lists 12 locations in 8 states (California, Ohio, Other).

Frequently Asked Questions

What is clinical trial NCT07219043 about?

NCT07219043 is a clinical study titled "A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation". In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection...

What is the current status of trial NCT07219043?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2026-01-05. Estimated completion is 2028-02-10.

What conditions does trial NCT07219043 study?

This clinical trial studies the following conditions: Microvascular Inflammation.

What interventions are being tested in trial NCT07219043?

The interventions under investigation include: Placebo (DRUG), Felzartamab (DRUG).

Who is sponsoring clinical trial NCT07219043?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07219043 being conducted?

This trial has 12 study locations across California, Minnesota, New Jersey, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT07219043's enrollment target sits among peer trials

81 834th of 2000 higher than 1,160 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07219043, the US trial registry maintained by the National Library of Medicine. NCT07219043 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.