Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000491460
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
21/05/2025
Date last updated
21/05/2025
Date data sharing statement initially provided
21/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the short-term effects of oral Roxadustat in volunteers over the age of 40.
Scientific title
An open-label volunteer study of the impact of short-term oral Roxadustat exposure on gene expression in whole blood in healthy adults aged 40 years and over.
Secondary ID [1] 314241 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications 337157 0
Surgical Site Infection 337158 0
Condition category
Condition code
Infection 333577 333577 0 0
Other infectious diseases
Surgery 333576 333576 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three doses of Roxadustat 100mg oral tablets taken on alternate days across a 5-day period i.e. 1x100mg on Day 1; 1x100mg on Day 3; 1x100mg on Day 5. Adherence will be monitored by completion of a Treatment Diary.
Intervention code [1] 330852 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341149 0
The number of differentially expressed genes in whole blood. An unselected approach using RNA sequencing will be adopted i.e. all genes changing expression levels significantly, with at least a 1.5-fold change, will be reported.
Timepoint [1] 341149 0
Baseline; 6 hours after dose 1; 6 hours after dose 3
Secondary outcome [1] 446505 0
Monocyte Heat Shock Protein 72
Timepoint [1] 446505 0
Baseline; 6 hours after dose 1; 6 hours after dose 3

Eligibility
Key inclusion criteria
1. Age 40 years or over
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Inability to provide informed consent
2. Peanut or Soya allergy
3. Pregnancy or breast feeding
4. Epilepsy
5. Severe liver disease (Childs Pugh C)
6. Current upper respiratory tract infection
6. Current bacterial infection

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. The mean (95% CI) number of Differentially Expressed Genes (DEGs) observed 6 hours after Dose 1 compared to baseline.
2. The mean (95% CI) number of DEGs observed 6 hours after Dose 3 compared to baseline.
3. The conserved DEGs observed in all participants after Dose 1.
4. The conserved DEGs observed in all participants after Dose 3.
5. Pathway analysis for conserved DEGs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
12/12/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27789 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 43979 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 318762 0
Government body
Name [1] 318762 0
National Health and Medical Research Council
Country [1] 318762 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Country
Australia
Secondary sponsor category [1] 321202 0
None
Name [1] 321202 0
Address [1] 321202 0
Country [1] 321202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317372 0
WA Health Central HREC
Ethics committee address [1] 317372 0
Ethics committee country [1] 317372 0
Australia
Date submitted for ethics approval [1] 317372 0
28/10/2024
Approval date [1] 317372 0
04/12/2024
Ethics approval number [1] 317372 0
RGS0000007340

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

Contacts
Principal investigator
Name 140846 0
A/Prof Andrew Toner
Address 140846 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 140846 0
Australia
Phone 140846 0
+61424231978
Fax 140846 0
Email 140846 0
[email protected]
Contact person for public queries
Name 140847 0
Andrew Toner
Address 140847 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 140847 0
Australia
Phone 140847 0
+61892242244
Fax 140847 0
Email 140847 0
[email protected]
Contact person for scientific queries
Name 140848 0
Andrew Toner
Address 140848 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 140848 0
Australia
Phone 140848 0
+61892242244
Fax 140848 0
Email 140848 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.