Treating BK Virus Infections in Kidney Transplant Recipients
An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
This study is testing if changing the way we manage immune suppression and giving a special treatment can help kidney transplant patients with BK virus infections feel better and keep their transplants healthy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 12 sites (Canberra, Australian Capital Territory and 11 other locations) |
| Trial ID | NCT05325008 on ClinicalTrials.gov |
What this trial studies
The BEAT-BK trial investigates the effects of modifying immunosuppression and administering intravenous immunoglobulin (IVIG) on BK virus infections in kidney and simultaneous kidney-pancreas transplant recipients. The study aims to balance the risks of excessive immunosuppression, which can lead to opportunistic infections, against the need to prevent acute rejection and graft loss. Participants will be monitored for allograft function, rejection rates, and overall health outcomes. The trial is informed by prior observational data and aims to provide a structured approach to managing BKPyV infections.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years or older who have received a kidney or simultaneous pancreas-kidney transplant and have confirmed BKPyV viremia.
Not a fit: Patients with contraindications to IVIG, current active acute rejection, or limited life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could improve treatment outcomes for kidney transplant recipients suffering from BK virus infections, potentially reducing graft loss and improving patient survival.
How similar studies have performed: While the use of IVIG in this context has not been extensively studied, other trials have explored similar immunosuppression strategies with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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 \<18 years) or other authorised person Exclusion Criteria: 1. Contraindications to receiving IVIG as a treatment 2. Current active acute rejection (≤ 3 months prior) 3. Treating clinicians would regard as unsafe to be enrolled 4. Limited life expectancy (\< 12 months) 5. Receiving Belatacept as part of their immunosuppression protocol 6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia 7. Prior infection and treatment for BKPyV-Viremia 8. Received IVIG treatment in the past with last IVIG treatment \< 4 weeks prior to randomisation
Where this trial is running
Canberra, Australian Capital Territory and 11 other locations
- Canberra Hospital — Canberra, Australian Capital Territory, Australia (Recruiting)
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
- Prince of Wales Hospital — Randwick, New South Wales, Australia (Recruiting)
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Recruiting)
- The Childrens Hospital Westmead — Sydney, New South Wales, Australia (Recruiting)
- Western Sydney Local Health District (Westmead Hospital) — Westmead, New South Wales, Australia (Recruiting)
- Queensland Children's Hospital — Brisbane, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Flinders Medical Centre — Adelaide, South Australia, Australia (Recruiting)
- Monash Health — Melbourne, Victoria, Australia (Recruiting)
- Perth Children's Hospital — Perth, Western Australia, Australia (Recruiting)
- Sir Charles Gairdner Hospital — Perth, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Misa Matsuyama, PhD
- Email: beat-bk@uq.edu.au
- Phone: +61 437 759 894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.