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

RecruitingPhase 3Ages 2 Years - anyAllThe University of Queensland
NCT05325008 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 2 years or above 2. Have received a kidney or simultaneous pancreas-kidney transplant 3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count ≥ 5,000 copies per mL, or histological confirmation of BKPyVAN, within 3 weeks prior to randomisation. 4. Be able to provide informed consent or consent given by a parent or guardian (if age \<18 years) or other authorised person Exclusion Criteria: 1. Contraindications to receiving IVIG as a treatment 2. Current active acute rejection (≤ 3 months prior) 3. Treating clinicians would regard as unsafe to be enrolled 4. Limited life expectancy (\< 12 months) 5. Receiving Belatacept as part of their immunosuppression protocol 6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia 7. Prior infection and treatment for BKPyV-Viremia 8. Received IVIG treatment in the past with last IVIG treatment \< 4 weeks prior to randomisation
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What it tests

  • Immunosuppression reduction/modification + intravenous immunoglobulin
  • Immunosuppression reduction/modification
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Where

13 sites
Canberra Hospital
Canberra, Australia
John Hunter Hospital
New Lambton Heights, Australia
Prince of Wales Hospital
Randwick, Australia
Royal Prince Alfred Hospital
Sydney, Australia
The Childrens Hospital Westmead
Sydney, Australia
Western Sydney Local Health District (Westmead Hospital)
Westmead, Australia
Queensland Children's Hospital
Brisbane, Australia
Townsville University Hospital
Townsville, Australia

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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