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A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients

Study acronym: BEAT-BK
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 12 to 13v10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 13 to 12v8
  4. Study sites: 8 to 13v7
  5. Study sites: 7 to 8v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 7
    • Eligibility criteria shortened, about 1 word
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 1, 2027 to Aug 1, 2027
    • Start date changed from estimate of Aug 1, 2023 to Aug 18, 2023
    • Site details revised
    v4
  3. Start date: Mar 1, 2023 to Aug 1, 2023
    • Study sites: 0 to 1
    v3
  4. Start date: Jun 1, 2022 to Mar 1, 2023v2 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 250 to 280
    • Primary completion date: Jun 1, 2027 to Jul 1, 2027
    • Study completion date: Nov 1, 2027 to Jun 30, 2029
    • Interventions: Intravenous immunoglobulin (Drug) to Immunosuppression reduction/modification (Other), Immunosuppression reduction/modification + intravenous immunoglobulin (Drug)
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 7 to 14
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BEAT-BK will see the effect of immunosuppression reduction/modification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).
Trial Details
NCT Number NCT05325008
Lead Sponsor The University of Queensland
Conditions
(from sponsor)		 BK Viremia, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
Related terms Kidney Diseases, Rejection, Psychology, Virus Diseases
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov