Treating BK Virus Infections in Kidney Transplant Recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Misa Matsuyama, PhD
• Email: beat-bk@uq.edu.au
• Phone: +61 437 759 894

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BK virus in kidney transplant patients and donors: who carries the virus and why

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• Using letermovir to prevent CMV infection in kidney and pancreas transplant patients

  This study is testing if letermovir can help prevent CMV infections in adult kidney and pancreas transplant patients who are at high risk, while reducing their need for another medication called ganciclovir.

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• Immune-guided versus universal antiviral prevention for CMV after kidney transplant

  We will test whether using immune-guided monitoring to decide who needs antiviral treatment works better than giving everyone three months of antiviral pills after a CMV-positive kidney transplant.

  Recruiting Phase 3 University Hospital, Rouen · Rouen · NCT05708508

• Comparing 7 days versus 14 days of antibiotics for kidney transplant patients with acute pyelonephritis

  This study is testing if kidney transplant patients with a certain type of kidney infection can be treated safely with just 7 days of antibiotics instead of the usual 14 days.

  Recruiting at 4 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Bordeaux and 8 other locations · NCT05597540

• Inducing immunological tolerance in kidney transplant patients using stem cell infusion

  This study is testing whether giving stem cells from the same donor to kidney transplant patients can help them stop taking their immunosuppressive medications safely.

  Recruiting Phase 1 University of California, Los Angeles · Los Angeles, California · NCT05525507

• Investigating tacrolimus metabolism in kidney transplant patients

  This study looks at how kidney transplant patients process a medication called tacrolimus over four years to see if it affects their kidney health and how genetics might play a role.

  Recruiting University Hospital, Grenoble · Grenoble, Auvergne-Rhône-Alpes and 1 other locations · NCT04526431

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.