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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) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)

StatusEnrolling by Invitation
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later May 28, 2031 → Dec 31, 2031
See other at-risk trials from Biogen

Record History

  1. Minor Study sites: 13 to 14
  2. Notable Primary and study completion pushed from May 28, 2031 to Dec 31, 2031 Trial arms changed: 1 → 2 · Eligibility criteria expanded, about 7 words Show 2 more changesShow less
    • Trial arms changed: 1 → 2
    • Eligibility criteria expanded, about 7 words
  3. Minor Study sites: 12 to 13v7
  4. Minor Trial sites expanded: 8 → 12 locationsv6
  5. Minor Trial sites expanded: 2 → 8 locationsv5
  6. Notable Enrollment increased: 120 → 201 participants Eligibility criteria expanded, about 69 words · Secondary endpoints revised (9) · Study description shortened, about 14 words · 1 morev4 Show 4 more changesShow less
    • Eligibility criteria expanded, about 69 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 14 words
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  7. Notable Trial status changed: Not Yet Recruiting → Enrolling by Invitation Study sites: 0 to 2 · Start date changed from estimate of Apr 6, 2026 to Apr 16, 2026v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 6, 2026 to Apr 16, 2026
  8. Minor Start date: Mar 10, 2026 to Apr 6, 2026 Eligibility criteria shortened, about 9 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
92 trials monitored
See 7 trials at risk
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly. Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI. This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study. The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. 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 one of the parent studies 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 their 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 their 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 after their final dose. * Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.
Trial Details
NCT Number NCT07444489
Lead Sponsor Biogen
Conditions Antibody-mediated Rejection, Microvascular Inflammation
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov