A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Biogen
Study ID
NCT07444489
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Antibody-mediated Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Felzartamab — DRUG
    Administered IV

Study Details

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed a condition called antibody-mediated rejection (AMR). AMR happens when the body's immune system creates antibodies that attack the transplanted kidney. In late AMR, this happens more than 6 months after the kidney transplant. It can lead to serious kidney problems over time. An earlier study called 299AR301 (TRANSCEND) (NCT06685757) began in 2024 and is investigating felzartamab in participants with AMR. It includes a treatment period of about 1 year. It first compares treatment with felzartamab to placebo for about 6 months and then all participants are given felzartamab to complete the study. This study, 299AR301 LTE, is a long-term extension of the parent study 299AR301. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years. The goals of this study are to learn more about the long-term safety and effects of felzartamab in people with AMR. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302. The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug. Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health. The study will be done as follows: * Participants who complete the final visit of the treatment period in the parent study can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits. * Participants who did not stop receiving felzartamab in the parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time. * Participants who stopped receiving felzartamab in the parent study will only attend study visits for health monitoring- they will not receive felzartamab. * Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle. * Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit 4 weeks after their final dose. * Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.

Key Dates

Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
May 28, 2031
Completion
May 28, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Long-Term Extension: Felzartamab
    Participants will receive felzartamab, intravenously (IV), once every 8 weeks for up to 200 weeks in the LTE period.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [ Time Frame: From first dose of study drug up to end of study follow-up (Up to Week 204) ]

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA College of MedicineLos AngelesCalifornia90095-
Cooperman Barnabas Medical CenterWest OrangeNew Jersey07039-

Find similar trials in Los Angeles, CA

By research site
UCLA College of Medicine· Los Angeles, CACooperman Barnabas Medical Center· West Orange, NJ

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