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Advancing Transplantation Outcomes in Children

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

Record History

  1. Notable Primary endpoints: details revised at 1 of 1 entry Study sites: 20 to 21 · Eligibility criteria expanded, about 34 words Show 2 more changesShow less
    • Study sites: 20 to 21
    • Eligibility criteria expanded, about 34 words
  2. Minor Site contacts updated at 1 of 20 sitesv22
  3. Minor Site contacts updated at 1 of 20 sitesv21
  4. Minor Site contacts updated at 2 of 20 sitesv20
  5. Minor Eligibility criteria expanded, about 74 words Secondary endpoints: details revised at 8 of 8 entries · Site contacts updated at 2 of 20 sitesv19 Show 2 more changesShow less
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site contacts updated at 2 of 20 sites

    See this version in full on ClinicalTrials.gov ↗

Show 17 earlier versionsHide 17 earlier versions
  1. Minor Site contacts updated at 2 of 20 sitesv18
  2. Minor Site details revised at 3 of 20 sitesv17
  3. Minor Study sites: 21 to 20v16
  4. Minor Primary and study completion dates: Nov 1, 2028 to Jun 30, 2028v15
  5. Minor Site details revised at 2 of 21 sitesv14
  6. Minor Site details revised at 2 of 21 sitesv13
  7. Minor Site details revised at 2 of 21 sitesv12
  8. Minor Site details revised at 1 of 21 sitesv11
  9. Minor Study sites: 20 to 21 Eligibility criteria shortened, about 5 wordsv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Site details revised at 1 of 20 sitesv9
  11. Minor Study sites revised (20)v8 See this version in full on ClinicalTrials.gov ↗
  12. Minor Site details revised at 1 of 20 sitesv7
  13. Minor Start date changed from estimate of May 24, 2024 to May 22, 2024v6
  14. Minor Study sites: 18 to 20 Start date: Apr 30, 2024 to May 24, 2024v5 Show 1 more changeShow less
    • Start date: Apr 30, 2024 to May 24, 2024
  15. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Feb 21, 2024 to Apr 30, 2024 · Eligibility criteria expanded, about 31 words · Study sites revised (18)v4 Show 3 more changesShow less
    • Start date: Feb 21, 2024 to Apr 30, 2024
    • Eligibility criteria expanded, about 31 words
    • Study sites revised (18)

    See this version in full on ClinicalTrials.gov ↗

  16. Minor Start date: Feb 15, 2024 to Feb 21, 2024 Study sites revised (18)v3 Show 1 more changeShow less
  17. Notable Start date: Nov 1, 2023 to Feb 15, 2024v2
  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.
This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.
Trial Details
NCT Number NCT06055608
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Kidney Transplant
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov