Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07219043
PHASE2

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

Sponsor: Biogen

View on ClinicalTrials.gov

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. In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI. 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 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.

Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2026-01-05

Completion Date

2028-02-10

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Felzartamab

Administered IV

DRUG

Placebo

Administered IV

Locations (15)

Keck Hispital of University of Southern California (USC)

Los Angeles, California, United States

Providence St. Joseph Hospital Orange

Orange, California, United States

Sutter Health - California Pacific Medical Center

San Francisco, California, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cooperman Barnabas Medical Center

West Orange, New Jersey, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Washington Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Medizinische Universität Wien

Vienna, Austria

Hospital de Base da Faculdade de Medicina de São José do Rio Preto

Vila São José, São José Do Rio Preto, Brazil

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Hospital Universitario Vall d'Hebron

Barcelona, Spain