A Phase 3 interventional study of Immunosuppression reduction/modification + intravenous immunoglobulin and Immunosuppression reduction/modification in BK Viremia, Kidney Transplant Infection and Kidney Transplant Failure and Rejection, sponsored by The University of Queensland. Recruiting at 13 sites in Australia. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by The University of Queensland · Phase 3, Interventional, and Treatment
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).
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.
656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.
This study's planned enrollment of 280 is above the median of 100 across 464 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin
Drug: Immunosuppression reduction/modification + intravenous immunoglobulin
Receives Immunosuppression reduction/modification as part of standard of care.
Other: Immunosuppression reduction/modification
Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.
Also known as: Human immunoglobulin
Participants will receive immunosuppression reduction/modification.
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.
Time frame: 11 - 13 weeks
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
Time frame: 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
Time frame: 12, 24 & 48 weeks
All cause death
Compare the mortality rate in the intervention and control groups.
Time frame: 12, 24 & 48 weeks
Graft loss
Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Hospitalisations due to infection events
Compare the number of hospitalisation due to infection between the intervention and control groups.
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.
Compare the number of infectious events requiring antimicrobial therapy between the intervention and control groups
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
Compare the outcomes of health-related quality of life between the intervention and control groups.
Time frame: 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
Time frame: 12 & 48 weeks
Any cancer diagnosis or cancer related death
Compare the incidence rate (number) of cancer outcomes between the intervention and control groups.
Time frame: 24 & 48 weeks
Composite ranked outcome
Compare the long-term composite ranked outcome between the intervention and control groups
Time frame: 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.
Time frame: Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Plan to share: No
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The University of Queensland