Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients

Prior treatment

• Long-term and excessive use of glucocorticoids (equivalent to prednisone \> 7.5 mg/day) or other drugs that may affect muscle metabolism (such as androgens).
• A kidney transplant is planned within the next six months.

Other illness

• Non-renal anemia: Anemia caused by other main reasons (such as thalassemia, megaloblastic anemia due to vitamin B12 or folic acid deficiency, active bleeding, hemolytic anemia, hematological malignancies, etc.).
• People who are allergic to roxadustat or any of its excipients.
• Uncontrolled hypertension (sitting systolic blood pressure remains \> 160 mmHg or diastolic blood pressure \> 100 mmHg after active antihypertensive treatment).
• There have been thrombotic events such as acute myocardial infarction, unstable angina pectoris, stroke, deep vein thrombosis or pulmonary embolism within the past six months.
• Those with known active malignant tumors or undergoing anti-tumor treatment (except for basal cell carcinoma, etc.) are excluded.
• Diseases affecting muscle metabolism and assessment:
• Diagnosed with chronic liver cirrhosis, acute exacerbation of chronic obstructive pulmonary disease (COPD), congestive heart failure (NYHA class IV), and other chronic diseases that seriously affect muscle metabolism.
• Due to severe limitations in limb movement caused by rheumatoid arthritis, Parkinson's disease, spinal cord injury, etc., it is impossible to complete muscle strength and functional tests.
• Other serious systemic diseases:
• Active, uncontrolled severe infection.

Lab values

• Severe liver dysfunction (Child-Pugh grade C or ALT/AST \> 3 times the upper limit of normal).

Age

• Pregnant or lactating women, or women of childbearing age who are unwilling to take effective contraceptive measures during the study period.

Other

• Contraindications and related risks of Roxadustat:
• Severe thyroid dysfunction (uncontrolled).
• Life expectancy is less than one year.
• Special circumstances related to the research:
• Has participated in any other interventional clinical trials within the past 3 months.
• Poor compliance and special populations:
• There are mental or cognitive impairments, making it impossible to understand or cooperate with the research.

• Age: 18 to 80 years old (inclusive), gender unrestricted.
• End-stage renal disease and maintenance hemodialysis for at least 16 weeks.
• The average Hb level is 7.0\~10.0 g/dL (the last two evaluations).
• And have not received or have discontinued ESA/roxadustat treatment.
• Vascular access: internal fistula or long-term hemodialysis catheter.
• Weight between 45-100 kg.
• Sarcopenia Diagnosis (Reference: AWGS 2019 Consensus):
• Decreased muscle strength: Male grip strength \< 28 kg, female grip strength \< 18 kg.
• Muscle mass decline: Assessed by bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA), it is characterized by appendicular skeletal muscle mass index (ASMI): \< 7.0 kg/m² for men and \< 5.7 kg/m² for women (BIA standard, the device and formula used should be specified).
• Sarcopenia can be diagnosed when both "decreased muscle strength" and "reduced muscle mass" are present. If resources permit, "decreased physical function" (such as a 6-meter walking speed \< 1.0 m/s) can be added as an indicator for severity grading.
• Voluntary participation in this study.
• Must be able to swallow tablets。