Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery. (PRELIFS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perioperative Anemia
• Intervention / Treatment: Drug: Roxadustat

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital of Zhejiang University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: FG-4592; Evrenzo
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Transfusion Rate	The percentage of participants in each group requiring red blood cell transfusion during the perioperative period.	Discharge or within 4 weeks of hospitalization (whichever comes first)
Volume of Blood Transfused	The total volume of red blood cells transfused in units per participant during the perioperative period.	Discharge or within 4 weeks of hospitalization (whichever comes first)
Hemoglobin Levels at Different Time Points	Hemoglobin levels will be measured at key time points to assess changes, including: at baseline (enrollment), pre-surgery, during surgery, at 1, 3, 5, 28 days post-surgery, and at 1 month and 6 months follow-up visits to monitor longer-term effects.	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	Levels of ferritin and other biomarkers related to anemia will be measured, including iron, transferrin, and vitamin B12, to assess the impact of Roxadustat on anemia.	Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.
Length of Hospital Stay	The total duration of hospitalization for each participant, measured in days.	Discharge or within 4 weeks of hospitalization (whichever comes first)
Hospitalization Costs	The total cost of the hospital stay for each participant, including all treatments and care.	Discharge or within 4 weeks of hospitalization (whichever comes first)
Thrombotic Events	Incidence of thrombotic events, including deep vein thrombosis, myocardial infarction, ischemic stroke, and pulmonary embolism.	From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
Hyperkalemia	Occurrence of elevated potassium levels (hyperkalemia) during the perioperative period.	From the start of medication until 3 days after the end of treatment.
Metabolic Acidosis	Incidence of metabolic acidosis as measured by blood gas analysis.	From the start of medication until 3 days after the end of treatment.
Neurological Side Effects (Dizziness, Drowsiness, Seizures)	Occurrence of neurological side effects, including dizziness, drowsiness, or seizures, reported by participants or physicians.	From the start of medication until 3 days after the end of treatment.
Gastrointestinal Side Effects	Incidence of gastrointestinal side effects, including nausea, vomiting, indigestion, and diarrhea.	From the start of medication until 3 days after the end of treatment.
Limb Edema	Occurrence of edema in the limbs during the medication period.	From the start of medication until 3 days after the end of treatment.
Upper Respiratory Tract Infections	Incidence of upper respiratory tract infections during the medication period.	From the start of medication until 3 days after the end of treatment.
Allergic Reactions	Occurrence of allergic reactions to the medication or other substances during the medication period.	From the start of medication until 3 days after the end of treatment.
Insomnia	Incidence of insomnia reported by participants during the medication period.	From the start of medication until 3 days after the end of treatment.
Acute Kidney Injury	Incidence of acute kidney injury as defined by KDIGO criteria.	From the start of surgery until hospital discharge or within 4 weeks post-surgery.
Postoperative Infections	Incidence of infections following surgery, including sepsis and pneumonia.	From the start of surgery until hospital discharge or within 4 weeks post-surgery.
Mortality Rate	All-cause mortality during the perioperative period and follow-up.	From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
MACE (Major Adverse Cardiovascular Events)	Incidence of MACE, including all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke.	From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
Other New Adverse Reactions	Any other newly reported adverse reactions that were not pre-specified but occurred during the perioperative period.	From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Min Yan, MD, PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Anemia; Transfusion; Roxadustat
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 2024-0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No