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: Julie Varghese (AKTN)
Clinical Research Associate: David Charman
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 to commence Q1 2023
Target Recruitment: 280 participants from Australia, New Zealand, Canada, Brazil, and Belgium.
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.