Phase 2 study for people with Chronic Kidney Disease
Not yet recruiting Phase 2
This trial at a glance
Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | NSW | Status not stated |
| Princess Alexandra Hospital | Woolloongabba | QLD | Status not stated |
| Royal Adelaide Hospital | Adelaide | SA | Status not stated |
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:
* End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy
* Aged \>60 years
Exclusion Criteria:
* Aged \<60 years
* Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)
* Recent infection (\<6 months) with proven Influenza A, Influenza B, or RSV
* Current use of immunosuppressive medications, including:
* Oral steroid at a dose equivalent of 5 mg/day prednisolone or greater
* Mycophenolate mofetil
* Azathioprine
* Calcineurin inhibitors
* mTOR inhibitors
* Recent use of intravenous immunosuppressive medications (\<6 months), including:
* T-cell depleting agents (e.g. anti-thymocyte globulin)
* B-cell depleting agents (e.g. rituximab)
* Cyclophosphamide
* Has a history of problems with side-effects associated with sirolimus use including
* Angioedema
* Active/recent opportunistic infection
* Current or prior interstitial lung disease, non-infectious pneumonitis, organising pneumonia, or pulmonary fibrosis
* Clinically significant pleural effusion or pericardial effusion
* Active non-healing wounds, chronic skin ulcers, or planned major surgery/procedures
* Current malignancy or recent malignancy with high recurrence risk
* Severe or uncontrolled hyperlipidaemia
* History of rhabdomyolysis
* Severe hepatic impairment
* Ongoing use of strong CYP3A4/P-gp inhibitors or inducers including
* Inhibitors: Ketoconazole, Voriconazole, Itraconazole, Telithromycin, Clarithromycin
* Inducers: Rifampicin, Rifabutin
* Unable or unwilling to provide informed consent to participate in the trial
* Known allergy to or intolerance of sirolimus (rapamycin) or the contents of the influenza or RSV vaccine
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: 14 May 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.