If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor The University of Queensland

Registry number NCT05325008

Started 18 August 2023 Today 16 October 2026 Estimated completion 1 August 2027

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Canberra Hospital	Canberra	ACT	Recruiting
John Hunter Hospital	New Lambton Heights	NSW	Recruiting
Prince of Wales Hospital	Randwick	NSW	Recruiting
Royal Prince Alfred Hospital	Sydney	NSW	Recruiting
The Childrens Hospital Westmead	Sydney	NSW	Recruiting
Western Sydney Local Health District (Westmead Hospital)	Westmead	NSW	Recruiting
Queensland Children's Hospital	Brisbane	QLD	Recruiting
Townsville University Hospital	Townsville	QLD	Recruiting
Princess Alexandra Hospital	Woolloongabba	QLD	Recruiting
Flinders Medical Centre	Adelaide	SA	Recruiting
Monash Health	Melbourne	VIC	Recruiting
Perth Children's Hospital	Perth	WA	Recruiting
Sir Charles Gairdner Hospital	Perth	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 2 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 280

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 18 August 2023

Estimated completion 1 August 2027

Registry last updated 8 June 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 8 June 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT05325008

Sponsor: The University of Queensland

Phase: Phase 3

Status: Recruiting

More information: https://clinicaltrials.gov/study/NCT05325008

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion 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

Exclusion Criteria:

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

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.