Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

NCT ID: NCT06772272

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2027-05-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roxadustat

Participants in this group will receive Roxadustat, administered orally at a dose of 100mg three times per week for a total of three weeks. This treatment will begin two weeks prior to the scheduled lumbar interbody fusion surgery and continue for one week postoperatively. The aim is to evaluate whether Roxadustat reduces perioperative blood transfusion requirements and assess its safety during the perioperative period.

Group Type: EXPERIMENTAL

Roxadustat

Intervention Type: DRUG

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.

Control

Participants in this group will receive standard clinical care according to the hospital's guidelines without the administration of Roxadustat. This group serves as a comparator to evaluate the effectiveness of Roxadustat in reducing perioperative blood transfusions during elective lumbar interbody fusion surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

FG-4592; Evrenzo

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years, no upper age limit, sex unrestricted.
• Scheduled for elective lumbar interbody fusion surgery.
• Diagnosed with anemia (Hemoglobin levels: male <130g/L, female <120g/L).
• Willing to participate and able to voluntarily sign an informed consent form.

Exclusion Criteria

• Patients admitted on an emergency basis.
• Patients with moderate to severe anemia (Hemoglobin levels <90g/L).
• Patients already enrolled in another clinical study.
• Patients unable to comply with the study protocol due to cognitive or language barriers.
• Pregnant or breastfeeding women.
• Patients who have already received erythropoiesis-stimulating agents, iron supplements, or other treatments to increase hemoglobin levels.
• Patients with severe infections.
• Patients with a history of acute coronary syndrome, heart failure, or cerebrovascular events within the last 3 months.
• Any other medical condition that may pose a safety risk, confound efficacy or safety evaluations, or interfere with study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Min Yan

Head of Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min Yan, MD, PhD

Role: STUDY_CHAIR

Zhejiang University

Locations

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2024-0037

Identifier Type: -

Identifier Source: org_study_id