A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Public ClinicalTrials.gov record NCT07219043. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07219043
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 81 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2026
- Primary completion
- Feb 9, 2028
- Completion
- Feb 9, 2028
- Last update posted
- Aug 26, 2026
2026 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92350 | Recruiting |
| Keck Hispital of University of Southern California (USC) | Los Angeles | California | 90033 | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Providence St. Joseph Hospital Orange | Orange | California | 92868 | Recruiting |
| Sutter Health - California Pacific Medical Center | San Francisco | California | 94115 | Recruiting |
| University of California San Fransisco (UCSF) Medical Center | San Francisco | California | 94158 | Recruiting |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109-5650 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| Cooperman Barnabas Medical Center | West Orange | New Jersey | 07039 | Recruiting |
| Duke University Hospital | Durham | North Carolina | 27710 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| The Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Penn Medicine - Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Recruiting |
| Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center | Richmond | Virginia | 23298 | Recruiting |
| University of Washington Medical Center | Seattle | Washington | 98195 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07219043, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07219043 live on ClinicalTrials.gov.