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Can a simple infusion save transplanted kidneys from a stealthy virus?

NCT ID NCT05325008

Disease control Sponsor: The University of Queensland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether reducing anti-rejection drugs, with or without an extra treatment called IVIG, can better control BK virus in kidney transplant patients. BK virus can damage the new kidney and lead to transplant failure. About 280 adults and children who have a kidney or kidney-pancreas transplant and a high level of BK virus will take part. The goal is to find the best way to protect the kidney while managing the virus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

BK-virus nephropathy kidney disorder Rejection, Psychology renal infectious disease viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BK viremia Kidney transplant failure and rejection Kidney transplant infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Canberra Hospital

    RECRUITING

    Canberra, Australian Capital Territory, 2605, Australia

  • Flinders Medical Centre

    RECRUITING

    Adelaide, South Australia, 5042, Australia

  • John Hunter Hospital

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Monash Health

    RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Prince of Wales Hospital

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Sir Charles Gairdner Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • The Childrens Hospital Westmead

    RECRUITING

    Sydney, New South Wales, 2145, Australia

  • Townsville University Hospital

    RECRUITING

    Townsville, Queensland, 4814, Australia

  • Western Sydney Local Health District (Westmead Hospital)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.