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

Study acronym: TRANSCEND
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status changed: Recruiting → Active, Not Recruiting Enrollment increased: 120 → 132 participants · Trial sites reduced: 59 → 56 locationsv42 Show 2 more changesShow less
    • Enrollment increased: 120 → 132 participants
    • Trial sites reduced: 59 → 56 locations
  2. Minor Study sites: 57 to 59v41
  3. Minor Study sites: 56 to 57v40
  4. Minor Study sites: 55 to 56v39
  5. Minor Study sites revised (55)v38 See this version in full on ClinicalTrials.gov ↗
Show 36 earlier versionsHide 36 earlier versions
  1. Minor Study sites: 52 to 55 Eligibility criteria expanded, about 19 words · Secondary endpoints revised (19) · Study description expanded, about 92 words · 1 morev37 Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (19)
    • Study description expanded, about 92 words
    • Study title expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites: 50 to 52v36
  3. Minor Study sites: 49 to 50v35
  4. Minor Study sites: 48 to 49v34
  5. Minor Study sites: 46 to 48v33
  6. Minor Study sites: 42 to 46v32
  7. Minor Study sites: 41 to 42v31
  8. Minor Study sites: 40 to 41v30
  9. Minor Study sites: 38 to 40v29
  10. Minor Study sites: 37 to 38v28
  11. Minor Study sites: 36 to 37v27
  12. Minor Site details revised at 1 of 36 sitesv26
  13. Minor Study sites: 35 to 36v25
  14. Minor Site details revised at 2 of 35 sitesv24
  15. Minor Study sites: 22 to 35v23
  16. Minor Study sites: 21 to 22v22
  17. Minor Study sites: 20 to 21v21
  18. Minor Study sites: 18 to 20v20
  19. Minor Study sites: 15 to 18v19
  20. Minor Study sites: 14 to 15v18
  21. Minor Study sites: 12 to 14 Eligibility criteria expanded, about 1 wordv17 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  22. Minor Study sites: 10 to 12v16
  23. Minor Study sites: 9 to 10v15
  24. Minor Study sites: 8 to 9v14
  25. Minor Study sites revised (8)v13 See this version in full on ClinicalTrials.gov ↗
  26. Minor Study sites revised (8)v12 See this version in full on ClinicalTrials.gov ↗
  27. Minor Start date: Dec 16, 2024 to Dec 3, 2024 Study sites revised (8)v11 Show 1 more changeShow less
  28. Minor Primary completion date: Dec 2026 to Dec 1, 2026 Completion date: Jun 2027 to Jun 1, 2027 · Start date: Dec 3, 2024 to Dec 16, 2024 · Study sites revised (8)v10 Show 3 more changesShow less
    • Completion date: Jun 2027 to Jun 1, 2027
    • Start date: Dec 3, 2024 to Dec 16, 2024
    • Study sites revised (8)

    See this version in full on ClinicalTrials.gov ↗

  29. Notable Lead sponsor: HI-Bio, A Biogen Company to Biogen Study sites revised (8) · Collaborators shortened, about 1 wordv9 Show 2 more changesShow less
    • Study sites revised (8)
    • Collaborators shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  30. Minor Re-verified, no change to tracked fieldsv8
  31. Minor Study sites: 7 to 8v7
  32. Minor Study sites: 5 to 7v6
  33. Minor Site details revised at 1 of 5 sitesv5
  34. Minor Eligibility criteria revisedv4 See this version in full on ClinicalTrials.gov ↗
  35. Minor Study sites: 3 to 5v3
  36. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 3 · Start date changed from estimate of Nov 2024 to Dec 3, 2024v2 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Nov 2024 to Dec 3, 2024
  1. 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
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In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment * Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year * Changes in kidney function from the start of treatment * How many people have biopsy results showing their kidney tissue looks normal again * How long the transplanted kidney keeps working * How many participants have medical problems during the study * How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52 * How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time * How felzartamab is processed by the body * How many participants develop antibodies against felzartamab in the blood The study will be done as follows: * Participants will be screened to check if they can join the study. This will take up to 42 days. * There will be 2 parts in this study. * Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo. * Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab. * All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight. * Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.
Trial Details
NCT Number NCT06685757
Lead Sponsor Biogen
Conditions Antibody-mediated Rejection
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov