A pilot study of preoperative Roxadustat in patients undergoing major surgery.

Hypoxic Enhancement Before Major Surgery (HYPE): A pilot randomised controlled trial of preoperative Roxadustat vs placebo in patients undergoing major surgery, assessing safety, effectiveness and feasibility.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000188538

Acronym

HYPE Pilot Study

Enrollment

150

Registered

2024-02-27

Start date

2024-06-14

Completion date

2026-02-17

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Complications after major surgery are common and decrease survival in the short and long-term. Tissue hypoxia (low oxygen) is established as a driver of postoperative complications. All complex cells can adapt to low oxygen conditions, over a period of hours to days, by activating the highly conserved hypoxia inducible factor (HIF) pathway. Roxadustat is a first-in-class oral prolyl hydroxylase inhibitor that increases HIF signalling and is currently marketed for the treatment of anaemia in chronic kidney disease. Brief preoperative Roxadustat exposure stands to prime cells to function well under the anticipated hypoxic stress of major surgery, a clinical insult that is unique due to its precise timing. In particular, Roxadustat may enhance immune cell function and healing in the hypoxic microenvironment of the surgical wound, thereby reducing the burden of surgical site infection. Hypothesis: A definitive phase 3 randomised controlled trial of preoperative roxadustat vs placebo in patients undergoing major noncardiac surgery is safe, feasible and justified.

Interventions

Roxadustat 100mg oral capsules taken on alternate days for four days up to and including the day of surgery i.e. 1st dose 4 days before surgery, 2nd dose 2 days before surgery, final dose on day of surgery. Adherence will be documented by participants in a treatment diary and checked by research team on day of surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 years or over 2. Undergoing elective major surgery including the following procedures: Oesophagectomy; Gastrectomy; Small bowel resection; Large bowel resection; Hepatectomy; Splenectomy; Pancreatectomy; Nephrectomy; Prostatectomy; Cystectomy; Adrenalectomy; Abdominal aneurysm repair (Open); Femoral-Popliteal Bypass; Total hip replacement; Total knee replacement; Spinal surgery (3 levels or more).

Exclusion criteria

1. Inability to provide informed consent 2. Peanut or soya allergy 3. Current viral or bacterial infection 4. Pregnancy or breast feeding 5. Epilepsy 6. Severe liver disease (Childs Pugh C)

Outcome results