NCT05325008 A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
| NCT ID | NCT05325008 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The University of Queensland |
| Condition | BK Viremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-08-18 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 280 participants in total. It began in 2023-08-18 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).
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
Contact & Investigator
Germaine Wong, Professor
STUDY CHAIR
University of Sydney
Frequently Asked Questions
Who can join the NCT05325008 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying BK Viremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05325008 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 280 participants.
Is NCT05325008 currently recruiting?
Yes, NCT05325008 is actively recruiting participants. Contact the research team at beat-bk@uq.edu.au for enrollment information.
Where is the NCT05325008 trial being conducted?
This trial is being conducted at Canberra, Australia, New Lambton Heights, Australia, Randwick, Australia, Sydney, Australia and 9 additional locations.
Who is sponsoring the NCT05325008 clinical trial?
NCT05325008 is sponsored by The University of Queensland. The principal investigator is Germaine Wong, Professor at University of Sydney. The trial plans to enroll 280 participants.