Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000698471p
Ethics application status
Submitted, not yet approved
Date submitted
8/06/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalising Aotearoa Lupus Medications: investigation of biomarkers for individualisation of therapy
Scientific title
Personalising Aotearoa Lupus Medications: investigation of biomarkers in patients diagnosed with systemic lupus erythematosus for individualisation of lupus nephritis therapy
Secondary ID [1] 309887 0
Auckland Medical Research Foundation project grant reference 1123002
Universal Trial Number (UTN)
Trial acronym
PALM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic lupus erythematosus (SLE) 330348 0
Lupus nephritis 330349 0
Condition category
Condition code
Inflammatory and Immune System 327192 327192 0 0
Autoimmune diseases
Renal and Urogenital 327193 327193 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
SLE Patients

Whole blood samples will be collected from SLE patients aged 18 years or older from the Auckland region who meet the inclusion and exclusion criteria and provide written informed consent.

For any SLE patients receiving therapeutics (e.g., cyclophosphamide (CP), mycophenolate mofetil (MMF), azathioprine, prednisone, etc.) during the study period, these blood samples will be taken immediately prior to their next dose in order to maximise drug washout in the sample (CTROUGH). Blood samples will be collected at the University of Auckland Clinical Research Centre or appropriate Health New Zealand Te Whatu Ora facilities.

Identifiable data will be stored separately to study data in a password-protected file on a secure University of Auckland study drive accessible only to the named study investigators. SLE patient demographics and medical history will be collected via a REDCap questionnaire prior to sample collection. For SLE patients, routine clinical data and treatment response and outcome data will be collected from patient records and entered into a secure REDCap database by the named study investigators. The follow-up period for collection of these data will be 6 months from the date of sample donation.

An optional sub-study will also be available for SLE patients enrolled in the primary study who are receiving either CP or MMF (induction or maintenance) as part of their routine care. These patients will be asked to provide post-dose blood samples to assess the clinical sensitivity of the DNA damage (CP patients) and inosine-5'-monophosphate dehydrogenase (IMPDH) activity/polymerisation (MMF patients) assays. There will be no requirement for the sub-study samples to be collected on the same day as the primary sample collection. A limited sampling strategy (LSS) will be employed (1h, 2h, 4h), based on previous work in patients prescribed MMF to prevent acute graft-versus-host disease. The published LSS for CP is based on intravenous delivery, but as it includes two identical timepoints to the MMF LSS, we will utilise the same sampling timepoints for CP to reduce study complexity.

For all primary study participants, up to 33 mL of blood (four tubes) will be collected, including at least one tube each of the PAXgene Blood DNA Tubes and the BD Vacutainer® CPT™ Mononuclear Cell Preparation Tubes (sodium citrate). An additional 24 mL of blood (three tubes) will be collected for SLE patients enrolled in the optional sub-study.
Intervention code [1] 326311 0
Not applicable
Comparator / control treatment
Comparator group: healthy volunteers

Whole blood samples will be collected from healthy volunteers aged 18 years or older from the Auckland region who meet the inclusion and exclusion criteria and provide written informed consent.

Identifiable data will be stored separately to study data in a password-protected file on a secure University of Auckland study drive accessible only to the named study investigators. Healthy volunteer demographics and medical history will be collected into a secure REDCap database prior to sample collection.

Up to 33 mL of blood (four tubes) will be collected, including at least one tube each of the PAXgene Blood DNA Tubes and the BD Vacutainer® CPT™ Mononuclear Cell Preparation Tubes (sodium citrate).
Control group
Active

Outcomes
Primary outcome [1] 341735 0
To assess IMPDH polymerisation in peripheral blood mononuclear cells (PBMC) treated with MPA ex vivo by fluorescence immunocytochemistry (ICC), as a potential novel pharmacodynamic biomarker of MMF outcomes in an Aotearoa New Zealand (AoNZ) SLE cohort (in comparison to healthy volunteers).
Timepoint [1] 341735 0
SLE patients: Baseline (immediately prior to next scheduled dose for patients receiving therapeutics (e.g., cyclophosphamide, MMF, azathioprine, prednisone, etc.) during the study period), 6-month outcome follow-up. Healthy volunteers: Baseline (single study visit)
Secondary outcome [1] 448561 0
To assess IMPDH activity in PBMC treated with MPA ex vivo by high-performance liquid chromatography (HPLC) +/- mass spectrometry (MS) in an AoNZ SLE cohort (in comparison to healthy volunteers)
Timepoint [1] 448561 0
SLE patients: Baseline (immediately prior to next scheduled dose for patients receiving therapeutics (e.g., cyclophosphamide, MMF, azathioprine, prednisone, etc.) during the study period). Healthy volunteers: Baseline (single study visit)
Secondary outcome [2] 448562 0
To assess the reproducibility of the quantitative polymerase chain reaction-block (QPCR-block) DNA damage repair assay data in an independent cohort
Timepoint [2] 448562 0
SLE patients: Baseline (immediately prior to next scheduled dose for patients receiving therapeutics (e.g., cyclophosphamide, MMF, azathioprine, prednisone, etc.) during the study period). Healthy volunteers: Baseline (single study visit)
Secondary outcome [3] 448563 0
To assess the feasibility of the DNA damage (QPCR-block) assay, and the IMPDH polymerisation (ICC) and activity (HPLC+/-MS) assays, to detect clinical doses of CP or MMF (respectively) in patients receiving them as part of their routine care. The will be undertaken by assessment of the sensitivity of the post-dose assays in comparison to that performed in the baseline samples.
Timepoint [3] 448563 0
Substudy participants only: Baseline (immediately prior to next scheduled dose for patients receiving therapeutics (e.g., cyclophosphamide, MMF, azathioprine, prednisone, etc.) during the study period). 1 hour post-dose (routine therapy) 2 hours post-dose (routine therapy) 4 hours post-dose (routine therapy)
Secondary outcome [4] 448564 0
To determine participant genotypes for pharmacogenes that may impact their MMF or CP treatment outcomes, using standard techniques (e.g. restriction fragment length polymorphism (RFLP)-PCR, sequencing, microarray) as appropriate for each pharmacogene of interest. This will include both assessment of known pharmacogenes for these medicines (e.g. CYP2C19, CYP2B6) and an exploratory analysis of other candidate genes.
Timepoint [4] 448564 0
SLE patients: Baseline (immediately prior to next scheduled dose for patients receiving therapeutics (e.g., cyclophosphamide, MMF, azathioprine, prednisone, etc.) during the study period), 6-month outcome follow-up. Healthy volunteers: Baseline (single study visit)

Eligibility
Key inclusion criteria
Systemic lupus erythematosus (SLE) cohort
• At least 18 years old
• Able to provide written informed consent
• Diagnosed with systemic lupus erythematosus (SLE)
Healthy volunteer cohort
• At least 18 years old
• Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Systemic lupus erythematosus (SLE) cohort
• Unable to provide a blood sample
• Unable to provide informed consent
Healthy volunteer cohort
• Current illness
• Current disease (including autoimmune diseases)
• Current medication use (excluding oral and implanted contraceptives)
• Pregnant or breastfeeding

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27111 0
New Zealand
State/province [1] 27111 0
Auckland

Funding & Sponsors
Funding source category [1] 314071 0
Charities/Societies/Foundations
Name [1] 314071 0
Auckland Medical Research Foundation (AMRF)
Country [1] 314071 0
New Zealand
Primary sponsor type
University
Name
Waipapa Taumata Rau, the University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321685 0
None
Name [1] 321685 0
Address [1] 321685 0
Country [1] 321685 0
Other collaborator category [1] 283542 0
Government body
Name [1] 283542 0
Health NZ | Te Whatu Ora – Waitemata
Address [1] 283542 0
Country [1] 283542 0
New Zealand
Other collaborator category [2] 283543 0
Government body
Name [2] 283543 0
Health NZ | Te Whatu Ora – Te Toka Tumai Auckland
Address [2] 283543 0
Country [2] 283543 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313211 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 313211 0
Ethics committee country [1] 313211 0
New Zealand
Date submitted for ethics approval [1] 313211 0
17/06/2025
Approval date [1] 313211 0
Ethics approval number [1] 313211 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127354 0
Dr Katie Burns
Address 127354 0
Department of Pharmacology and Clinical Pharmacology, Waipapa Taumata Rau, the University of Auckland
Country 127354 0
New Zealand
Phone 127354 0
+64 9 923 8877
Fax 127354 0
Email 127354 0
[email protected]
Contact person for public queries
Name 127355 0
Katie Burns
Address 127355 0
Department of Pharmacology and Clinical Pharmacology, Waipapa Taumata Rau, the University of Auckland
Country 127355 0
New Zealand
Phone 127355 0
+64 9 923 8877
Fax 127355 0
Email 127355 0
[email protected]
Contact person for scientific queries
Name 127356 0
Katie Burns
Address 127356 0
Department of Pharmacology and Clinical Pharmacology, Waipapa Taumata Rau, the University of Auckland
Country 127356 0
New Zealand
Phone 127356 0
+64 9 923 8877
Fax 127356 0
Email 127356 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.