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NCT05325008
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Conditions: BK Viremia, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 280
Sponsor: The University of Queensland
Location: Canberra Hospital Canberra Australian Capital Territory
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 \
Source: ClinicalTrials.gov (NCT05325008). StuddyBuddy aggregates publicly available trial information.
