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Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.

Study acronym: BRUNO-PIC
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 2 to Phase 4 Primary endpoint revised · Eligibility criteria shortened, about 51 words · Secondary endpoints: 7 to 6 · 2 morev6 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria shortened, about 51 words
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 29 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint revised Eligibility criteria shortened, about 14 words · Secondary endpoints: 6 to 7 · Study description expanded, about 3 wordsv5 Show 3 more changesShow less
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 12, 2024 to Aug 5, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Aug 12, 2024 to Aug 5, 2024
    • Site details revised
  5. Enrollment target: 90 to 45 Study arms: 2 to 1v2 Show 1 more changeShow less
    • Study arms: 2 to 1
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.
Trial Details
NCT Number NCT06529536
Lead Sponsor Murdoch Childrens Research Institute
Conditions Solid Organ Transplant
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov