Status:
RECRUITING
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Lead Sponsor:
The University of Queensland
Conditions:
BK Viremia
Kidney Transplant Infection
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
BKPyV infection is a rare but also devastating disease in kidney and SPK transplant recipients. Immunosuppression used in transplantation minimises the risk of acute rejection and eventual graft loss,...
Eligibility Criteria
Inclusion
- Aged 2 years or above
- Have received a kidney or simultaneous pancreas-kidney transplant
- 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.
- Be able to provide informed consent or consent given by a parent or guardian (if age \<18 years) or other authorised person
Exclusion
- Contraindications to receiving IVIG as a treatment
- Current active acute rejection (≤ 3 months prior)
- Treating clinicians would regard as unsafe to be enrolled
- Limited life expectancy (\< 12 months)
- Receiving Belatacept as part of their immunosuppression protocol
- Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia
- Prior infection and treatment for BKPyV-Viremia
- Received IVIG treatment in the past with last IVIG treatment \< 4 weeks prior to randomisation
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05325008
Start Date
August 18 2023
End Date
June 30 2029
Last Update
July 1 2025
Active Locations (12)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
2
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050