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Clinical Trials in the USA / NCT07219043
Recruiting Phase 2

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

NCT07219043 · tracked via the Priya Life Science USA tracker
Sponsor
Biogen
Phase
Phase 2
Started
2026-01-05
Last updated
2026-09-18

Condition(s) studied

Microvascular Inflammation

Investigational drug(s) / intervention(s)

FelzartamabPlacebo

Felzartamab: Administered IV

Placebo: Administered IV

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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 stopping) prior treatment. * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors). * DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization. Key Exclusion Criteria: * Transplant: Blood type (ABO)-incompatible transplant. * History of multiple organ transplants including en bloc and dual kidney transplants. * Presence of HLA donor-specific antibodies. * Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator. * Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing MVI≥2 and DSA negative status and to determine eligibility: 1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or plasma exchange (PLEX). 2. Complement system inhibitors (e.g., eculizumab). 3. Proteasome inhibitors (e.g., bortezomib). 4. The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab. 5. Any B cell-depleting therapy (including anti-CD20 agents \[e.g., rituximab\]) within 3 months prior to randomization. 6. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Loma Linda University Medical Center Loma Linda California Recruiting
Keck Hispital of University of Southern California (USC) Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Providence St. Joseph Hospital Orange Orange California Recruiting
Sutter Health - California Pacific Medical Center San Francisco California Recruiting
University of California San Fransisco (UCSF) Medical Center San Francisco California Recruiting
University of Colorado Aurora Colorado Recruiting
The University of Kansas Medical Center Kansas City Kansas Recruiting
University of Michigan Medical Center Ann Arbor Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Cooperman Barnabas Medical Center West Orange New Jersey Recruiting
Duke University Hospital Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Penn Medicine - Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center Richmond Virginia Recruiting
University of Washington Medical Center Seattle Washington Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Instituto de Trasplante y Alta Complejidad (ITAC) Buenos Aires Ciudad Autónoma de Buenos Aires (caba) Recruiting
Clínica Privada Vélez Sarsfield Córdoba Argentina Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Princess Alexandra Hospital Brisbane Queensland Recruiting
Medizinische Universität Wien Vienna Austria Recruiting
Hospital de Base da Faculdade de Medicina de São José do Rio Preto Vila São José São José Do Rio Preto Recruiting
Hospital do Rim - Fundação Oswaldo Ramos São Paulo Brazil Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) São Paulo Brazil Recruiting
Alberta Health Services (AHS) - University of Alberta Hospital Edmonton Alberta Recruiting
Institut klinicke a experimentalni mediciny (IKEM) Prague Czechia Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux France Recruiting
Centre Hospitalier Universitaire (CHU) de GreNble Alpes - Hôpital Michallon La Tronche France Recruiting
Hospices Civils de Lyon - Hôpital Édouard Herriot Lyon France Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse France Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden Dresden Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting

+ 5 more sites — see the full list on the official registry below.

More Biogen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219043 on ClinicalTrials.gov ↗ ← All trials in the USA