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Tocilizumab in Cardiac Transplantation

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 29, 2026 Eligibility criteria expanded, about 87 words · Secondary endpoints: details revised at 8 of 20 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 87 words
    • Secondary endpoints: details revised at 8 of 20 entries
    • Study description revised
    • Site details revised at 1 of 20 sites
  2. Secondary endpoints: details revised at 6 of 20 entriesv41
  3. Re-verified, no change to tracked fieldsv40
  4. Primary endpoint revised Secondary endpoints: 22 to 20v39 Show 1 more changeShow less
    • Secondary endpoints: 22 to 20

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv38
Show 36 earlier versionsHide 36 earlier versions
  1. Primary and study completion dates: Mar 21, 2025 to Mar 25, 2025v37
  2. Trial status: Active, Not Recruiting to Completed Primary and study completion dates changed from estimate of Apr 30, 2025 to Mar 21, 2025v36 Show 1 more changeShow less
    • Primary and study completion dates changed from estimate of Apr 30, 2025 to Mar 21, 2025
  3. Re-verified, no change to tracked fieldsv35
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 385 · Study sites: 22 to 20v34 Show 2 more changesShow less
    • Enrollment target: estimated 200 to confirmed 385
    • Study sites: 22 to 20
  5. Primary completion date: Aug 2022 to Apr 30, 2025 Completion date: Aug 2023 to Apr 30, 2025v33 Show 1 more changeShow less
    • Completion date: Aug 2023 to Apr 30, 2025
  6. Site details revised at 1 of 22 sites Collaborators expanded, about 3 wordsv32 Show 1 more changeShow less
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 1 of 22 sitesv31
  8. Site details revised at 2 of 22 sitesv30
  9. Site details revised at 1 of 22 sitesv29
  10. Eligibility criteria expanded, about 64 words Study sites revised (22)v28 Show 1 more changeShow less
    • Study sites revised (22)

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 19 to 22v27
  12. Site details revised at 1 of 19 sitesv26
  13. Study sites: 18 to 19v25
  14. Study sites: 17 to 18v24
  15. Study sites revised (17)v23 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 16 to 17v22
  17. Study sites: 15 to 16v21
  18. Site details revised at 4 of 15 sitesv20
  19. Study sites: 14 to 15 Eligibility criteria expanded, about 30 wordsv19 Show 1 more changeShow less
    • Eligibility criteria expanded, about 30 words

    See this version in full on ClinicalTrials.gov ↗

  20. Site details revised at 7 of 14 sitesv18
  21. Site details revised at 1 of 14 sitesv17
  22. Site details revised at 1 of 14 sitesv16
  23. Site details revised at 1 of 14 sitesv15
  24. Site details revised at 1 of 14 sitesv14
  25. Site details revised at 1 of 14 sitesv13
  26. Site details revised at 1 of 14 sitesv12
  27. Site details revised at 1 of 14 sitesv11
  28. Site details revised at 1 of 14 sitesv10
  29. Site details revised at 1 of 14 sitesv9
  30. Start date: Nov 30, 2018 to Dec 20, 2018v8
  31. 2 versions Re-verified since Dec 4, 2018, no change to tracked fieldsv6-v7
  32. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2018 to Nov 30, 2018 · Site details revised at 14 of 14 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2018 to Nov 30, 2018
    • Site details revised at 14 of 14 sites
  33. Start date: Oct 2018 to Nov 2018v4
  34. Start date: Sep 2018 to Oct 2018v3
  35. Start date: Aug 2018 to Sep 2018v2
  1. 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.
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.
Trial Details
NCT Number NCT03644667
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: PPD Development, LP
Conditions Heart Transplant
Enrollment 385 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov