Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

NCT06772272 | Active Not Recruiting Phase 3

• 1 other identifier: 2024-0037
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Keywords

Anemia; Roxadustat; Transfusion; Surgery

Outcome Measures

Primary Outcomes (1)

• Perioperative RBC transfusion requirement

  The incidence of the composite outcome of perioperative transfusion requirement (defined as the occurrence of one or more of the following events): * Red blood cell transfusion * Perioperative lowest hemoglobin level below 80 g/L

  Discharge or within 4 weeks of hospitalization (whichever comes first)

Secondary Outcomes (20)

• Blood Transfusion Rate

  Discharge or within 4 weeks of hospitalization (whichever comes first)

• Volume of Blood Transfused

  Discharge or within 4 weeks of hospitalization (whichever comes first)

• Hemoglobin Levels at Different Time Points

  Baseline, pre-surgery, during surgery, 1, 3, 5, and 28 days post-surgery, and at 1 month and 6 months follow-up.

• Ferritin and Anemia-Related Blood Tests

  Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.

• Length of Hospital Stay

  Discharge or within 4 weeks of hospitalization (whichever comes first)

Study Arms (2)

Roxadustat

EXPERIMENTAL

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.

Drug: Roxadustat

Control

NO INTERVENTION

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.

Interventions

Roxadustat 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.

Also known as: FG-4592, Evrenzo

Roxadustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Min Yan, MD, PhD

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Anesthesiology

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: January 13, 2025
• Study Start: November 10, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): May 10, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)