NCT06772272

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery: a Parallel-group, Open-label, Randomised Controlled Trial.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess whether Roxadustat can reduce perioperative blood transfusions in patients with anemia undergoing elective lumbar interbody fusion surgery. It will also evaluate the safety of Roxadustat in this context. The main questions it aims to answer are: * Does Roxadustat reduce the need for perioperative red blood cell transfusions? * Is Roxadustat safe for use in patients during the perioperative period? Researchers will compare Roxadustat to standard clinical care without Roxadustat to determine its effectiveness and safety. Participants will: * Take Roxadustat orally three times a week for three weeks (two weeks before surgery and one week post-surgery). * Undergo regular blood tests and follow-up monitoring during the hospital stay and up to 6 months after surgery.

Conditions

• Perioperative Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Roxadustat is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) used to treat anemia. Participants in the Roxadustat group will receive 100mg of Roxadustat orally three times per week for three weeks (two weeks prior to surgery and one week post-surgery). The dosage may be adjusted based on hemoglobin levels during the perioperative period: if hemoglobin rises above 150g/L, the drug will be stopped; if hemoglobin increases by more than 20g/L from baseline but is still below 130g/L, the dosage will be reduced to 70mg; if hemoglobin drops by more than 20g/L from baseline, the dosage will be increased to 120mg.

Timeline

• Start date: 2024-11-10
• Primary completion: 2026-11-10
• Completion: 2027-05-10
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China