Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients.
Francois Helle, Aurélien Aubry, Virginie Morel...
https://pubmed.ncbi.nlm.nih.gov/39352862Actively Recruiting
Phase 3
Age: 2Years +
All Genders
ID05325008
An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
Led by The University of Queensland · Updated on 2026-06-08
280
Participants Needed
13
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates polyomavirus infections (BKPyV) in people who have received kidney or simultaneous pancreas-kidney transplants. The study aims to evaluate how reducing or modifying immunosuppression, with or without intravenous immunoglobulin (IVIG), affects BKPyV infection, transplant function, graft loss, acute rejection, immunosuppression levels, and survival. BKPyV infection is a serious complication due to the immune system suppression needed after transplantation, which can increase infection risks and damage the transplant. Participants will be randomly assigned to one of two groups: one receiving immunosuppression reduction or modification plus IVIG, and the other receiving immunosuppression reduction or modification alone as part of standard care. The immunosuppression adjustments may include dose reductions or switches to less potent medications. IVIG is an antibody treatment with potential antiviral and immune-modulating effects, used here as an additional therapy for BKPyV infection. During the study, participants will be monitored for up to 48 weeks with assessments including viral load, kidney function (eGFR), transplant rejection, antibody presence, infection events, hospitalizations, quality of life, cancer diagnosis, and adverse events. The main outcome measured at 11 to 13 weeks combines death, graft loss, kidney function decline, rejection, viral load, and immunosuppression load. Safety and treatment effects will be closely followed throughout the study period.
CONDITIONS
Brief 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
You may qualify if you...
- Aged 2 years or above
- Have received a kidney or simultaneous pancreas-kidney transplant
- Have BKPyV-Viremia with a viral count 6 5,000 copies/mL or histological confirmation of BKPyV-associated nephropathy within 3 weeks before randomisation
- Able to provide informed consent or have consent given by a parent, guardian, or authorised person if under 18 years old
You will not qualify if you...
- Contraindications to receiving intravenous immunoglobulin (IVIG) treatment
- Current active acute rejection within the past 3 months
- Considered unsafe to enroll by treating clinicians
- Limited life expectancy 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 less than 4 weeks before randomisation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Up to 12 weeks
Participants receive immunosuppression reduction or modification, with some also receiving intravenous immunoglobulin as part of their treatment.
Weekly visits for up to 12 weeks
Follow-up
Duration - Up to 48 weeks after treatment
Participants are monitored for health outcomes including viral load, graft function, rejection, infections, and adverse events.
Visits at 24 and 48 weeks after treatment
Trial Site Locations
Total: 13 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
Townsville University Hospital
Townsville, Queensland, Australia, 4814
Actively Recruiting
9
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
10
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Actively Recruiting
11
Monash Health
Melbourne, Victoria, Australia, 3168
Actively Recruiting
12
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
13
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
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Research Team
M
Misa Matsuyama, PhD
P
Pushparaj Velayudham
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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