A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
BEAT-BK
An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
1 other identifier
interventional
280
1 country
12
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2023
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
March 30, 2026
March 1, 2026
4 years
January 10, 2022
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.
All participants will be allocated a rank at 12 weeks between rank 5 (worst) and rank 1 (best). The primary comparison of interest is between participants randomised to intravenous immunoglobulin (IVIG) and participants randomised to the control arm. Outcome measures include: Rank 5 - all cause death, allograft loss, eGFR decline ≥10mls/min 1.73². Rank 4 - acute allograft rejection or BK viral load to \>1000 copies/mL. Ranks 3, 2, and 1 - the degree of immunosuppression reduction relative to baseline immunosuppression.
11 - 13 weeks
Secondary Outcomes (14)
BKPyV final viral load
12 weeks
eGFR decline
12, 24 & 48 weeks
All cause death
12, 24 & 48 weeks
Graft loss
12, 24 & 48 weeks
Acute rejection of kidney and/or pancreas allografts
12 & 48 weeks
- +9 more secondary outcomes
Study Arms (2)
Immunosuppression reduction/modification + Intravenous Immunoglobulin
EXPERIMENTALReceives Immunosuppression reduction/modification + Intravenous Immunoglobulin
Immunosuppression reduction/modification
OTHERReceives Immunosuppression reduction/modification as part of standard of care.
Interventions
Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.
Participants will receive immunosuppression reduction/modification.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Receiving Belatacept as part of their immunosuppression protocol
- Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia
- Prior infection and treatment for BKPyV-Viremia
- Received IVIG treatment in the past with last IVIG treatment \< 4 weeks prior to randomisation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
The Childrens Hospital Westmead
Sydney, New South Wales, 2145, Australia
Western Sydney Local Health District (Westmead Hospital)
Westmead, New South Wales, 2145, Australia
Queensland Children's Hospital
Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Monash Health
Melbourne, Victoria, 3168, Australia
Perth Children's Hospital
Perth, Western Australia, 6009, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Related Publications (1)
Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
PMID: 39352862DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Germaine Wong, Professor
University of Sydney
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
April 13, 2022
Study Start
August 18, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
June 30, 2029
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share