A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Microvascular Inflammation
In brief
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.
Key facts
- Study ID
- NCT07219043
- Run by
- Biogen
- People needed
- 81
- Starts
- 2026-01-05
- Expected to finish
- 2028-02-10
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
- Keck Hispital of University of Southern California (USC) — Los Angeles, California, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Providence St. Joseph Hospital Orange — Orange, California, United States (enrolling)
- Sutter Health - California Pacific Medical Center — San Francisco, California, United States (enrolling)
- University of California San Fransisco (UCSF) Medical Center — San Francisco, California, United States (enrolling)
- The University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- University of Michigan Medical Center — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Cooperman Barnabas Medical Center — West Orange, New Jersey, United States (enrolling)
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- The Ohio State University — Columbus, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center — Richmond, Virginia, United States (enrolling)
- University of Washington Medical Center — Seattle, Washington, United States (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
- Instituto de Trasplante y Alta Complejidad (ITAC) — Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina (enrolling)
- Clínica Privada Vélez Sarsfield — Córdoba, Argentina (enrolling)
- Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (enrolling)
Full record on ClinicalTrials.gov
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