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

RecruitingPhase 3

Sponsor: The University of Queensland

Conditions: BK Viremia, Kidney Transplant Infection, Kidney Transplant Failure and Rejection

Interventions: Immunosuppression reduction/modification + intravenous immunoglobulin, Immunosuppression reduction/modification

Countries: Australia

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).

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (13)

Canberra, Australian Capital Territory, Australia
New Lambton Heights, New South Wales, Australia
Randwick, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Townsville, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Perth, Western Australia, Australia