A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorThe University of Queensland
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Immunosuppression reduction/modification + intravenous immunoglobulin
- Immunosuppression reduction/modification
Treatment groups
280 Participants
are divided into 2 treatment groupsLocations
13Canberra Hospital2605, CanberraAustralian Capital Territory, Australia
John Hunter Hospital2305, New Lambton HeightsNew South Wales, Australia
Prince of Wales Hospital2031, RandwickNew South Wales, Australia
Royal Prince Alfred Hospital2050, SydneyNew South Wales, Australia
Sponsors and collaborators
The University of Queensland
Lead sponsor
Source ClinicalTrials.gov