drugset / Trial / NCT06772272

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

NCT06772272

Phase 3 Active not recruiting 158 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-10
Primary completion
2026-11-10
Completion
2027-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Roxadustat Small molecule 100 mg Oral

Indications