An adaptive, randomised controlled trial to treat polyomavirus infections (BKPyV) in kidney and kidney-pancreas transplant recipients
Principal Investigators: Professor Germaine Wong
Clinical Project Manager: Pushparaj Velayudham
Clinical Research Associate: Misa Matsuyama
Trial Number: AKTN 20.07
Population: patients aged ≥2 years with high levels of BK Polyomavirus following a kidney or both kidney & pancreas transplant.
Intervention: Immunosuppression modification/reduction plus intravenous Immunoglobulin (IVIG) or Immunosuppression modification/reduction alone.
Follow-up: 12 months
Primary outcome: The study has a composite ranked global score comprised of avoidance of early mortality, avoidance of early graft loss, avoidance of worsening of allograft function, able to achieve viral clearance, avoidance of acute rejection, and reduction in immunosuppression load.
Status: Recruitment open
Target Recruitment: 280 participants globally.
Trial Summary
BK Polyomavirus (BKPyV) is most often the cause of kidney and simultaneous pancreas-kidney (SPK) transplant failure. About 1 in 20 transplant patients will get a serious BK virus infection that will lead to loss of kidney function. Unfortunately, about half of these patients will lose their transplant within 5 years.
The best way to treat serious BK virus infections is not known. The way that doctors currently treat the virus infection is to help the immune system. Doctors do this by reducing the drugs that have been used to dampen your natural immunity after transplant (i.e., your immunosuppression drugs).
The study’s aim is to find out if intravenous immunoglobulin (IVIG), along with reducing immunosuppression medicine, will help to fight the BK virus infection and reduce the incidence of kidney transplant loss.
BEAT-BK is a multi-centre, adaptive, randomised, two-arm trial of immunosuppression reduction/modification (standard of care) with and without IVIG in kidney and SPK recipients with BKPyV infections.
The study has been funded by MRFF Rare Cancers, Rare Diseases, and Unmet Needs grant.
Patient information – video and PDF
Where is the trial being conducted?
The trial is currently recruiting at:
ACT
Canberra Hospital
NSW
John Hunter Hospital
Prince of Wales Hospital
Royal Prince Alfred Hospital
The Children’s Hospital at Westmead
Westmead Hospital
QLD
Princess Alexandra Hospital
Queensland Children’s Hospital
SA
Flinders Medical Centre
VIC
Monash Health
WA
Perth Children’s Hospital
Sir Charles Gairdner Hospital