Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07219043 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: TRANSPIRE
StatusRecruiting
PhasePhase 2
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 45 to 46
  2. Study sites: 44 to 45 Eligibility criteria expanded, about 18 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 18 words
  3. Study sites: 43 to 44v31
  4. Study sites: 42 to 43v30
  5. Study sites: 41 to 42v29
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 40 to 41v28
  2. Study sites: 39 to 40v27
  3. Study sites: 38 to 39v26
  4. Study sites: 37 to 38v25
  5. Study sites: 35 to 37v24
  6. Study sites: 34 to 35v23
  7. Study sites: 32 to 34v22
  1. Trial sites expanded: 26 → 32 locationsv21
  2. Study sites: 24 to 26v20
  3. Study sites: 23 to 24v19
  4. Study sites: 22 to 23v18
  5. Trial sites expanded: 17 → 20 locationsv17
  6. Study sites: 17 to 20v16
  7. Study sites: 16 to 17v15
  8. Study sites: 15 to 16v14
  9. Study sites: 14 to 15v13
  10. Study sites: 12 to 14 Eligibility criteria expanded, about 66 words · Secondary endpoints revised (16) · Study description expanded, about 4 wordsv12 Show 3 more changesShow less
    • Eligibility criteria expanded, about 66 words
    • Secondary endpoints revised (16)
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 11 to 12v11
  12. Study sites: 9 to 11v10
  13. Study sites: 7 to 9v9
  14. Study sites: 6 to 7v8
  15. Study sites: 5 to 6v7
  16. Study sites: 4 to 5v6
  17. Study sites: 2 to 4v5
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Dec 1, 2025 to Jan 5, 2026 · Study title revisedv4 Show 3 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Dec 1, 2025 to Jan 5, 2026
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  19. Start date: Nov 17, 2025 to Dec 1, 2025v3
  20. Study sites: 0 to 1v2
  21. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Biogen
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 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.
Trial Details
NCT Number NCT07219043
Lead Sponsor Biogen
Conditions Microvascular Inflammation
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov