Phase 3 study
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| John Hunter Hospital | Lambton | NSW | Not yet recruiting |
| Prince of Wales Hospital | Randwick | NSW | Not yet recruiting |
| The Sydney Children's Hospital Network | Westmead | NSW | Not yet recruiting |
| Westmead Hospital | Westmead | NSW | Recruiting |
| Queensland Children's Hospital | South Brisbane | QLD | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | QLD | Not yet recruiting |
| Royal Adelaide Hospital | Adelaide | SA | Not yet recruiting |
| Monash Medical Centre | Clayton | VIC | Not yet recruiting |
| Fiona Stanley Hospital | Murdoch | WA | Not yet recruiting |
| Royal Perth Children's hospital | Nedlands | WA | Not yet recruiting |
| Sir Charles Gairdner Hospital | Nedlands | WA | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
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:
* Participants or their legal guardian must be able to understand and provide written informed consent;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* All ethnic and gender groups will have equal access to the study;
* All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven \*acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).
* Individuals with the following are eligible for inclusion:
i. Concurrent acute TCMR and microvascular inflammation (MVI) defined as g+ptc, but without ABMR diagnosis.
ii. Concurrent acute TCMR and chronic active TCMR.
Exclusion Criteria:
Individuals meeting any of the following criteria will be excluded from participation:
* Mixed rejection.
* Active or chronic active ABMR.
* Chronic active TCMR.
* Isolated v1 without inflammation.
* Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.
* Active malignancies or active infection that preclude immunosuppression augmentation.
* Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.
* Enrolment in other interventional drug trials.
* Use of other investigational agents.
* Unable to adhere to the study protocol.
Dates on the record
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: 31 August 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.