BK ViremiaPhase 3BEAT-BKNCT05325008
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
A Phase 3 study testing Immunosuppression reduction/modification + intravenous immunoglobulin and Immunosuppression reduction/modification in people with BK Viremia and Kidney Transplant Infection, run by The University of Queensland at 13 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- BK Viremia, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- What is being tested?
- Immunosuppression reduction/modification + intravenous immunoglobulin and Immunosuppression reduction/modification
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 13 sitesAustralia
- Study dates
- 18 Aug 2023to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Australia13 sites, 13 recruiting
- Recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
Merin Kuriakose, CN, (08) 8204 6281, Merin.Kuriakose@sa.gov.au
CN, (08) 8204 6281
- Recruiting
Queensland Children's Hospital
Brisbane, Queensland, 4101
Sophie Anderson-James
Anna Francis, Dr
- Recruiting
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Andrea Blanco, 02 5124 2146, Andrea.Blanco@act.gov.au
Lizanne Mackintosh, 02 5124 2526, Lizanne.Mackintosh@act.gov.au
- Recruiting
Monash Health
Melbourne, Victoria, 3168
Rita Barbis, 03 9594 3523, rita.barbis@monashhealth.org
Laura Chen, 03 9594 3049, laura.chen2@monashhealth.org
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Denise Jones, 02 4921 4332, Denise.jones@health.nsw.gov.au
Melissa Mulholland, 02 4921 4332, Melissa.Mulholland@health.nsw.gov.au
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
Nick Larkins, Dr, +61 8 6456 2222, Nicholas.Larkins@health.wa.gov.au
Nick Larkins, Dr
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Wai Lim, Prof, +61 8 6457 3333, wai.lim@health.wa.gov.au
Wai Lim, Prof
- Recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Jacquiline Pearse, (02) 9382 4444, Jacqueline.Pearse@health.nsw.gov.au
Hannah Kim, (02) 9382 4418, Jong.Kim1@health.nsw.gov.au
- Recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Christina Gong, 61 2 9515 4980, christina.gong@health.nsw.gov.au
Lin Lin, 61 2 9515 4980, Lin.Lin1@health.nsw.gov.au
- Recruiting
The Childrens Hospital Westmead
Sydney, New South Wales, 2145
Siah Kim, Dr, +61 421454723, siah.kim@health.nsw.gov.au
Siah Kim, Dr
- Recruiting
Townsville University Hospital
Townsville, Queensland, 4814
Belinda Elford, Belinda.Elford@health.qld.gov.au
Jennifer King, Jennifer.King2@health.qld.gov.au
- Recruiting
Western Sydney Local Health District (Westmead Hospital)
Westmead, New South Wales, 2145
Penelope Murrie, 02 8890 6848, Penelope.Murie@health.nsw.gov.au
Sana Hamilton, 02 8890 3883, sana.hamilton@health.nsw.gov.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Rachael Hale, 07 3176 6325, Rachael.Hale@health.qld.gov.au
Diana Leary, 07 3176 6325, Diana.leary@health.qld.gov.au
About this study
Official title: 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).
Read the 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.
- Being tested
- Immunosuppression reduction/modification + intravenous immunoglobulin, Immunosuppression reduction/modification
- Keywords
- Kidney transplantation, Intravenous immunoglobulin, Virus, Nephropathy, Clinical trial, Nephrology
- Medical subject headings
- Rejection, Psychology, Virus Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppression reduction/modification + intravenous immunoglobulinDrug
Also called Human immunoglobulin
Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.
Immunosuppression reduction/modificationOther
Participants will receive immunosuppression reduction/modification.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression reduction/modification + Intravenous Immunoglobulin | Experimental | Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin Receives: Drug: Immunosuppression reduction/modification + intravenous immunoglobulin |
| Immunosuppression reduction/modification | Other | Receives Immunosuppression reduction/modification as part of standard of care. Receives: Other: Immunosuppression reduction/modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 - 13 weeks
Secondary outcomes (14)
BKPyV final viral load
Compare the number of participants in the intervention and control groups with a BK Polyomavirus viral load to <1000 copies/mL
Measured: 12 weeks
eGFR decline
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
Measured: 12, 24 & 48 weeks
All cause death
Compare the mortality rate in the intervention and control groups.
Measured: 12, 24 & 48 weeks
Graft loss
Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.
Measured: 12, 24 & 48 weeks
Acute rejection of kidney and/or pancreas allografts
Compare the number of acute rejections (cellular and antibody mediated) episodes between the intervention and control groups.
Measured: 12 & 48 weeks
Donor Specific Anti-HLA Antibody
Compare the number of participants that develop de novo donor-specific antibodies between the intervention and control groups
Measured: 12 & 48 weeks
Infusion reactions and/ or venous thromboembolism events
Compare the incidence rate (number) of infusion reactions and venous thromboembolism between the intervention and control groups
Measured: 12 weeks
Hospitalisations due to infection events
Compare the number of hospitalisation due to infection between the intervention and control groups.
Measured: 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.
Compare the number of infectious events requiring antimicrobial therapy between the intervention and control groups
Measured: 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
Compare the outcomes of health-related quality of life between the intervention and control groups.
Measured: Baseline, 12, 24 & 48 weeks
BK polyomavirus associated nephropathy events
Compare the number of participants that develop BK polyomavirus associated nephropathy between the intervention and control groups
Measured: 12 & 48 weeks
Any cancer diagnosis or cancer related death
Compare the incidence rate (number) of cancer outcomes between the intervention and control groups.
Measured: 24 & 48 weeks
Composite ranked outcome
Compare the long-term composite ranked outcome between the intervention and control groups
Measured: 24 & 48 weeks
Adverse events of special interest and serious adverse events
Compare the incidence rate (number) of safety related events between intervention and control group.
Measured: Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start18 Aug 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BK ViremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Germaine Wong, Professor, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325008
- Sponsor's protocol ID
- AKTN 20.07
- Acronym
- BEAT-BK
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39352862
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
- ClinicalTrials.gov ID
- NCT05325008
- Acronym / sponsor ID
- BEAT-BK / AKTN 20.07
- Keywords
- Kidney transplantation, Intravenous immunoglobulin, Virus, Nephropathy, Clinical trial, Nephrology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression reduction/modification + Intravenous Immunoglobulin | Experimental | Drug: Immunosuppression reduction/modification + intravenous immunoglobulinReceives Immunosuppression reduction/modification + Intravenous Immunoglobulin |
| Immunosuppression reduction/modification | Other | Other: Immunosuppression reduction/modificationReceives Immunosuppression reduction/modification as part of standard of care. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppression reduction/modification + intravenous immunoglobulinAlso: Human immunoglobulinParticipants will receive intravenous immunoglobulin along with immunosuppression reduction/modification. | Drug | Immunosuppression reduction/modification + Intravenous Immunoglobulin |
| Immunosuppression reduction/modificationParticipants will receive immunosuppression reduction/modification. | Other | Immunosuppression reduction/modification |
Primary outcome
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.
14 secondary outcomes
BKPyV final viral load
Time frame: 12 weeks
eGFR decline
Time frame: 12, 24 & 48 weeks
All cause death
Time frame: 12, 24 & 48 weeks
Graft loss
Time frame: 12, 24 & 48 weeks
Acute rejection of kidney and/or pancreas allografts
Time frame: 12 & 48 weeks
Donor Specific Anti-HLA Antibody
Time frame: 12 & 48 weeks
Infusion reactions and/ or venous thromboembolism events
Time frame: 12 weeks
Hospitalisations due to infection events
Time frame: 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
EuroQol-5 Dimension-5 Level for adults/ Health Utilities Index-3 for children
Time frame: Baseline, 12, 24 & 48 weeks
BK polyomavirus associated nephropathy events
Time frame: 12 & 48 weeks
Any cancer diagnosis or cancer related death
Time frame: 24 & 48 weeks
Composite ranked outcome
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 39352862Helle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Germaine Wong, Professor study chair
University of Sydney
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunosuppression reduction/modification + intravenous immunoglobulin and Immunosuppression reduction/modification in people with BK Viremia and Kidney Transplant Infection, run by The University of Queensland at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Misa Matsuyama, PhD (+61 437 759 894, beat-bk@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05325008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.