ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postoperative Complications

Surgical Site Infection

Condition category

Condition code

Surgery

Other surgery

Infection

Other infectious diseases

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline; 6 hours after dose 1; 6 hours after dose 3

Secondary outcome [1]

Monocyte Heat Shock Protein 72

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WA Health Central HREC

Ethics committee address [1]

HREC Ethics Coordinator; 0892222269; HREC@health.wa.gov.au. Perth Business Centre, Perth, WA 6849. PO Box 8172

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2024

Approval date [1]

04/12/2024

Ethics approval number [1]

RGS0000007340

Summary

Brief summary

Roxadustat is a first-in-class oral prolyl hydroxylase inhibitor, marketed since 2019 exclusively for the treatment of anaemia in chronic kidney disease. Roxadustat increases hypoxia inducible factor (HIF) signalling, the primary mediator of the body’s normal adaptive response to low oxygen levels. HIF is a transcription factor that influences the expression of over 400 genes relating to energy production when oxygen is scarce (glycolysis), improved tissue oxygen delivery (erythropoiesis and angiogenesis), cell survival under stress and enhanced innate immunity. All of these biological mechanisms play a key role in favourable outcomes after the tissue injury of major surgery and the associated stress response. The HYPE Pilot Study (RGS0000006528, SMHS HREC, ACTRN12624000188538) is a separately registered double-blind phase 2 RCT that is currently recruiting at Royal Perth Hospital to explore the safety and potential benefit of three preoperative doses of Roxadustat 100mg in patients undergoing major noncardiac surgery. It remains unclear to what extent such brief Roxadustat exposure changes gene expression in the key pathways outlined above. The HYPE Volunteer Study (RGS0000007340, Central HREC) will complement the HYPE Pilot Study by improving understanding in this area i.e. will potentially substantiate any clinical effects observed in the HYPE Pilot Study and may support a subsequent phase 3 trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andrew Toner

Address

Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000

Country

Australia

Phone

+61424231978

Fax

[email protected]

Contact person for public queries

Name

Andrew Toner

Address

Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000

Country

Australia

Phone

+61892242244

Fax

[email protected]

Contact person for scientific queries

Name

Andrew Toner

Address

Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000

Country

Australia

Phone

+61892242244

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically