Actively Recruiting

Phase 3
Age: 2Years +
All Genders
NCT05325008

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

Led by The University of Queensland · Updated on 2026-03-30

280

Participants Needed

12

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 2 years or above
  • Received a kidney or simultaneous pancreas-kidney transplant
  • Have BKPyV-Viremia with viral count ≥ 5,000 copies/mL or histological confirmation of BKPyVAN within 3 weeks before randomization
  • Able to provide informed consent or have consent given by a parent, guardian, or authorized person if under 18 years
Not Eligible

You will not qualify if you...

  • Contraindicated for intravenous immunoglobulin (IVIG) treatment
  • Currently have active acute rejection within the last 3 months
  • Considered unsafe for enrollment by treating clinicians
  • Have a limited life expectancy of less than 12 months
  • Receiving Belatacept as part of immunosuppression
  • Currently undergoing or 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 treatment less than 4 weeks before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Canberra Hospital

Canberra, Australian Capital Territory, Australia, 2605

Actively Recruiting

2

John Hunter Hospital

New Lambton Heights, New South Wales, Australia, 2305

Actively Recruiting

3

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

4

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050

Actively Recruiting

5

The Childrens Hospital Westmead

Sydney, New South Wales, Australia, 2145

Actively Recruiting

6

Western Sydney Local Health District (Westmead Hospital)

Westmead, New South Wales, Australia, 2145

Actively Recruiting

7

Queensland Children's Hospital

Brisbane, Queensland, Australia, 4101

Actively Recruiting

8

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

9

Flinders Medical Centre

Adelaide, South Australia, Australia, 5042

Actively Recruiting

10

Monash Health

Melbourne, Victoria, Australia, 3168

Actively Recruiting

11

Perth Children's Hospital

Perth, Western Australia, Australia, 6009

Actively Recruiting

12

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia, 6009

Actively Recruiting

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Research Team

M

Misa Matsuyama, PhD

CONTACT

P

Pushparaj Velayudham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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