Status:
NOT_YET_RECRUITING
Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Sarcopenia
Anemia Associated With Chronic Kidney Disease (CKD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Sarcopenia, abbreviated as muscle loss, is a prevalent complication among patients with chronic kidney disease (CKD), particularly those with end - stage renal disease (ESRD). It significantly impacts...
Detailed Description
Sarcopenia, commonly abbreviated as age-related muscle loss, represents a highly prevalent and serious complication among patients suffering from chronic kidney disease (CKD), particularly those advan...
Eligibility Criteria
Inclusion
- 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。
Exclusion
- 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.).
- Contraindications and related risks of Roxadustat:
- 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:
- Severe thyroid dysfunction (uncontrolled).
- 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.
- 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).
- Other serious systemic diseases:
- Severe liver dysfunction (Child-Pugh grade C or ALT/AST \> 3 times the upper limit of normal).
- Active, uncontrolled severe infection.
- Life expectancy is less than one year.
- Special circumstances related to the research:
- A kidney transplant is planned within the next six months.
- 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.
- Pregnant or lactating women, or women of childbearing age who are unwilling to take effective contraceptive measures during the study period.
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07162090
Start Date
September 10 2025
End Date
December 31 2026
Last Update
September 9 2025
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