A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation (NCT07219043)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Loma Linda University Medical Center — Loma Linda, California
Age range: 18 Years to 74 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- Loma Linda University Medical Center — Loma Linda, California
- Keck Hispital of University of Southern California (USC) — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Providence St. Joseph Hospital Orange — Orange, California
- Sutter Health - California Pacific Medical Center — San Francisco, California
- University of California San Fransisco (UCSF) Medical Center — San Francisco, California
- The University of Kansas Medical Center — Kansas City, Kansas
- University of Michigan Medical Center — Ann Arbor, Michigan
- Mayo Clinic Rochester — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- Cooperman Barnabas Medical Center — West Orange, New Jersey
- Duke University Hospital — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- Penn Medicine - Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- Houston Methodist Hospital — Houston, Texas
- Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center — Richmond, Virginia
- University of Washington Medical Center — Seattle, Washington
- Medical College of Wisconsin — Milwaukee, Wisconsin
- Instituto de Trasplante y Alta Complejidad (ITAC) — Buenos Aires, Ciudad Autónoma de Buenos Aires (caba)
- Clínica Privada Vélez Sarsfield — Córdoba,
- Westmead Hospital — Westmead, New South Wales
📞 Contact the Study Coordinator
Phone: (866) 633-4636
Email: clinicaltrials@biogen.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: * In Part A, participants will receive their assigned drug for 24 weeks.
Explore by condition: All Microvascular Inflammation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.