A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients (BEAT-BK)

March 26, 2026 updated by: The University of Queensland

An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BKPyV infection is a rare but also devastating disease in kidney and SPK transplant recipients. Immunosuppression used in transplantation minimises the risk of acute rejection and eventual graft loss, but suppression of the immune system increases the risk of opportunistic infections and reactivation of latent viruses causing disease, such as BKPyV infection. Therefore, balancing the complications of excessive versus inadequate immunosuppression is a key priority for patients and health professionals. The BEAT-BK trial is designed through a structured, consensus process, and informed by the pilot observational data generated by the investigators. The conventional immunosuppression reduction approach may include judicious reduction in the doses of calcineurin inhibitors and anti-proliferative agents, or conversion to less potent immunosuppression therapy such as a switch from tacrolimus to cyclosporine, or mycophenolate to azathioprine. While adjuvant therapy is not commonly used, 63% of participants would consider IVIG as a 'rescue', when conventional therapy has failed, or the graft function is deteriorating rapidly. IVIG is a nondepleting agent containing natural antibodies with potential antiviral and immunomodulatory properties. It is used against some chronic infections (Epstein-Barr virus) and the treatment of antibody-mediated rejection in kidney transplantation. In BKPyV infection, the certainty of the evidence for IVIG is very low due to imprecision, and high risk of bias (small, case series, retrospective cohorts), but it holds promise based on findings from our observational data (n = 50). Recipients with BKPyV-DNAemia who received IVIG as adjuvant therapy were more likely to achieve complete viral clearance at 12 months (77.3% vs. 33.3%, p < 0.01) and less likely to relapse (11% vs. 27.3%, p=0.01) compared to recipients who received conventional therapy alone.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
      • Randwick, New South Wales, Australia, 2031
      • Sydney, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Kate Wyburn
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • The Childrens Hospital Westmead
        • Contact:
        • Principal Investigator:
          • Siah Kim
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Western Sydney Local Health District (Westmead Hospital)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Germaine Wong, Professor
        • Sub-Investigator:
          • Dharshana Sabanayagam, Doctor
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland CHILDREN'S HOSPITAL
        • Contact:
          • Sophie Anderson-James
        • Principal Investigator:
          • Anna Francis
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajiv Juneja
    • Victoria
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
        • Contact:
        • Principal Investigator:
          • Nick Larkins
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Contact:
        • Principal Investigator:
          • Wai Lim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunosuppression reduction/modification + Intravenous Immunoglobulin
Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin
Drug: Immunosuppression reduction/modification + intravenous immunoglobulin
Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.
Other Names:
  • Human immunoglobulin
Other: Immunosuppression reduction/modification
Receives Immunosuppression reduction/modification as part of standard of care.
Other: Immunosuppression reduction/modification
Participants will receive immunosuppression reduction/modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.
Time Frame: 11 - 13 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
BKPyV final viral load
Time Frame: 12 weeks
Compare the number of participants in the intervention and control groups with a BK Polyomavirus viral load to <1000 copies/mL
12 weeks
eGFR decline
Time Frame: 12, 24 & 48 weeks
Compare the number of participants in the intervention and control groups with an estimated glomerular filtration rate (eGFR) decline ≥ 10 ml/min/1.73 m2
12, 24 & 48 weeks
All cause death
Time Frame: 12, 24 & 48 weeks
Compare the mortality rate in the intervention and control groups.
12, 24 & 48 weeks
Graft loss
Time Frame: 12, 24 & 48 weeks
Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.
12, 24 & 48 weeks
Acute rejection of kidney and/or pancreas allografts
Time Frame: 12 & 48 weeks
Compare the number of acute rejections (cellular and antibody mediated) episodes between the intervention and control groups.
12 & 48 weeks
Donor Specific Anti-HLA Antibody
Time Frame: 12 & 48 weeks
Compare the number of participants that develop de novo donor-specific antibodies between the intervention and control groups
12 & 48 weeks
Infusion reactions and/ or venous thromboembolism events
Time Frame: 12 weeks
Compare the incidence rate (number) of infusion reactions and venous thromboembolism between the intervention and control groups
12 weeks
Hospitalisations due to infection events
Time Frame: Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Compare the number of hospitalisation due to infection between the intervention and control groups.
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Number of infectious events requiring antimicrobial (antibacterial, antiviral, antifungal, antiprotozoal) therapy.
Time Frame: Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Compare the number of infectious events requiring antimicrobial therapy between the intervention and control groups
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
EuroQol-5 Dimension-5 Level for adults/ Health Utilities Index-3 for children
Time Frame: Baseline, 12, 24 & 48 weeks
Compare the outcomes of health-related quality of life between the intervention and control groups.
Baseline, 12, 24 & 48 weeks
BK polyomavirus associated nephropathy events
Time Frame: 12 & 48 weeks
Compare the number of participants that develop BK polyomavirus associated nephropathy between the intervention and control groups
12 & 48 weeks
Any cancer diagnosis or cancer related death
Time Frame: 24 & 48 weeks
Compare the incidence rate (number) of cancer outcomes between the intervention and control groups.
24 & 48 weeks
Composite ranked outcome
Time Frame: 24 & 48 weeks
Compare the long-term composite ranked outcome between the intervention and control groups
24 & 48 weeks
Adverse events of special interest and serious adverse events
Time Frame: Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Compare the incidence rate (number) of safety related events between intervention and control group.
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Investigators

  • Study Chair: Germaine Wong, Professor, University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKTN 20.07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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