Perioperative AnemiaPhase 3PRELIFSNCT06772272
Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.
A Phase 3 study testing Roxadustat in people with Perioperative Anemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Anemia
- What is being tested?
- Roxadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 10 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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?
Read more
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
- Being tested
- Roxadustat
- Keywords
- Anemia, Roxadustat, Transfusion, Surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called FG-4592, Evrenzo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Discharge or within 4 weeks of hospitalization (whichever comes first)
Secondary outcomes (20)
Blood Transfusion Rate
The percentage of participants in each group requiring red blood cell transfusion during the perioperative period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the start of medication until 3 days after the end of treatment.
Insomnia
Incidence of insomnia reported by participants during the medication period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start10 Nov 2024
- Primary completion10 Nov 2026 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnemiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Min Yan, MD, PhD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772272
- Sponsor's protocol ID
- 2024-0037
- Acronym
- PRELIFS
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery: a Parallel-group, Open-label, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06772272
- Acronym / sponsor ID
- PRELIFS / 2024-0037
- Conditions
- Perioperative Anemia
- Keywords
- Anemia, Roxadustat, Transfusion, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Drug: RoxadustatParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatAlso: FG-4592, EvrenzoRoxadustat 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. | Drug | Roxadustat |
Primary outcome
Perioperative RBC transfusion requirement
Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)
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
20 secondary outcomes
Blood Transfusion Rate
Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)
Volume of Blood Transfused
Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)
Hemoglobin Levels at Different Time Points
Time frame: 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
Time frame: Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.
Length of Hospital Stay
Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)
Hospitalization Costs
Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)
Thrombotic Events
Time frame: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
Hyperkalemia
Time frame: From the start of medication until 3 days after the end of treatment.
Metabolic Acidosis
Time frame: From the start of medication until 3 days after the end of treatment.
Neurological Side Effects (Dizziness, Drowsiness, Seizures)
Time frame: From the start of medication until 3 days after the end of treatment.
Gastrointestinal Side Effects
Time frame: From the start of medication until 3 days after the end of treatment.
Limb Edema
Time frame: From the start of medication until 3 days after the end of treatment.
Upper Respiratory Tract Infections
Time frame: From the start of medication until 3 days after the end of treatment.
Allergic Reactions
Time frame: From the start of medication until 3 days after the end of treatment.
Insomnia
Time frame: From the start of medication until 3 days after the end of treatment.
Acute Kidney Injury
Time frame: From the start of surgery until hospital discharge or within 4 weeks post-surgery.
Postoperative Infections
Time frame: From the start of surgery until hospital discharge or within 4 weeks post-surgery.
Mortality Rate
Time frame: From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
MACE (Major Adverse Cardiovascular Events)
Time frame: From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
Other New Adverse Reactions
Time frame: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan, MD, PhD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roxadustat in people with Perioperative Anemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative RBC transfusion requirement (time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.