BridgeMD
New treatment option for BK Viremia
Official title A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
ClinicalTrials.gov ID: NCT05325008
What this study is testing
What is Immunosuppression reduction/modification + intravenous immunoglobulin?
Immunosuppression reduction/modification + intravenous immunoglobulin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bk viremia.
Also referred to as Human immunoglobulin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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...
- Be able to provide informed consent or consent given by a parent or guardian (if age \<18 years) or other authorised person
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canberra, Australian Capital Territory, Australia
- New Lambton Heights, New South Wales, Australia
- Randwick, New South Wales, Australia
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Brisbane, Queensland, Australia
- Townsville, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canberra, Australian Capital Territory, Australia; New Lambton Heights, New South Wales, Australia; Randwick, New South Wales, Australia; Sydney, New South Wales, Australia; Westmead, New South Wales, Australia; Brisbane, Queensland, Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.