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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
NCT07219043 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2028-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219043
The ClinicalTrials.gov registry entry for NCT07219043 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07219043 reports 12 study locations spanning 8 distinct geographic areas — top geographies include California, Ohio, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07219043?
The interventions under investigation include: Placebo (DRUG), Felzartamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07219043?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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