An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Queensland Children's Hospital
RECRUITING
Brisbane
Canberra Hospital
RECRUITING
Canberra
Monash Health
RECRUITING
Melbourne
John Hunter Hospital
RECRUITING
New Lambton Heights
Perth Children's Hospital
RECRUITING
Perth
Sir Charles Gairdner Hospital
RECRUITING
Perth
Prince of Wales Hospital
RECRUITING
Randwick
Royal Prince Alfred Hospital
RECRUITING
Sydney
The Childrens Hospital Westmead
RECRUITING
Sydney
Western Sydney Local Health District (Westmead Hospital)
RECRUITING
Westmead
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Contact Information
Primary
Peta-Anne Paul-Brent
beat-bk@uq.edu.au
+61 411 397 776
Backup
Pushparaj Velayudham
beat-bk@uq.edu.au
+61 438 077 278
Time Frame
Start Date: 2023-08-18
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 280
Treatments
Experimental: Immunosuppression reduction/modification + Intravenous Immunoglobulin
Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin
Other: Immunosuppression reduction/modification
Receives Immunosuppression reduction/modification as part of standard of care.
Related Therapeutic Areas
Sponsors
Leads: The University of Queensland