Felzartamab for Antibody-Mediated Rejection
(TRANSCEND LTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Medical Director
Principal Investigator
Biogen
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Long-Term Extension Treatment
Participants receive felzartamab intravenously once every 8 weeks for up to 200 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a safety follow-up visit 4 weeks after the final dose
What Are the Treatments Tested in This Trial?
Interventions
- Felzartamab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive felzartamab, intravenously (IV), once every 8 weeks for up to 200 weeks in the LTE period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada
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