A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transpla
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
| Condition(s) | Microvascular Inflammation |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Key Inclusion Criteria: * MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria. * Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b): 1. Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries 2. Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery * For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or s |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Lead sponsor | Biogen |
| Locations | Loma Linda, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; San Francisco, California, United States (+26 more sites) |
| Start date | 2026-01-05 |
| NCT ID | NCT07219043 |
| Official listing | https://clinicaltrials.gov/study/NCT07219043 |