A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Launched by THE UNIVERSITY OF QUEENSLAND · Apr 4, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The BEAT-BK clinical trial is studying how different treatments can help patients who have had a kidney or simultaneous kidney and pancreas transplant and are experiencing a viral infection called BKPyV. This virus can cause serious problems, including kidney transplant failure. The trial will look at the effects of reducing or modifying medications that suppress the immune system, with and without an additional treatment called IVIG, to see how these changes impact the virus, kidney function, and overall health.
To join the trial, participants need to be at least 2 years old, have received a kidney or pancreas-kidney transplant, and have a specific level of BKPyV infection. There are certain conditions that would prevent someone from participating, such as recent active rejection of the transplant or other health concerns. Participants in the trial can expect close monitoring and support as researchers work to find the best ways to manage this viral infection and improve transplant outcomes. This study is currently recruiting new participants, and it's open to individuals of all genders.
Gender
ALL
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
About The University Of Queensland
The University of Queensland (UQ) is a leading research institution located in Australia, renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a strong emphasis on collaboration between academia, industry, and healthcare communities, UQ leverages its extensive resources and expertise to conduct high-quality research aimed at improving patient outcomes. The university's multidisciplinary approach facilitates the exploration of diverse therapeutic areas, ensuring rigorous scientific methodologies and adherence to ethical standards. UQ's dedication to fostering a culture of discovery positions it at the forefront of clinical research, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Randwick, New South Wales, Australia
Woolloongabba, Queensland, Australia
Perth, Western Australia, Australia
Sydney, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Perth, Western Australia, Australia
Sydney, New South Wales, Australia
Canberra, Australian Capital Territory, Australia
Adelaide, South Australia, Australia
Brisbane, Queensland, Australia
Melbourne, Victoria, Australia
Westmead, New South Wales, Australia
Sydney, New South Wales, Australia
Patients applied
Trial Officials
Germaine Wong, Professor
Study Chair
University of Sydney
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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