[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anemia-associated-with-chronic-kidney-disease-ckd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anemia-associated-with-chronic-kidney-disease-ckd":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100605405","phase-4-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitors-on-sarcopenia-in-hemodialysis-patients-100605405",false,"NCT07162090","Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients","Observation of the Impact of Hypoxia - Inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients","HIF-PHI","Inclusion Criteria:\n\n* Age: 18 to 80 years old (inclusive), gender unrestricted.\n* End-stage renal disease and maintenance hemodialysis for at least 16 weeks.\n* The average Hb level is 7.0\\~10.0 g\u002FdL (the last two evaluations).\n* And have not received or have discontinued ESA\u002Froxadustat treatment.\n* Vascular access: internal fistula or long-term hemodialysis catheter.\n* Weight between 45-100 kg.\n* Sarcopenia Diagnosis (Reference: AWGS 2019 Consensus):\n* Decreased muscle strength: Male grip strength \\\u003C 28 kg, female grip strength \\\u003C 18 kg.\n* 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): \\\u003C 7.0 kg\u002Fm² for men and \\\u003C 5.7 kg\u002Fm² for women (BIA standard, the device and formula used should be specified).\n* 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 \\\u003C 1.0 m\u002Fs) can be added as an indicator for severity grading.\n* Voluntary participation in this study.\n* Must be able to swallow tablets。\n\nExclusion Criteria:\n\n* 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.).\n* Contraindications and related risks of Roxadustat:\n* People who are allergic to roxadustat or any of its excipients.\n* Uncontrolled hypertension (sitting systolic blood pressure remains \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg after active antihypertensive treatment).\n* 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.\n* Those with known active malignant tumors or undergoing anti-tumor treatment (except for basal cell carcinoma, etc.) are excluded.\n* Diseases affecting muscle metabolism and assessment:\n* Severe thyroid dysfunction (uncontrolled).\n* 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.\n* 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.\n* Long-term and excessive use of glucocorticoids (equivalent to prednisone \\> 7.5 mg\u002Fday) or other drugs that may affect muscle metabolism (such as androgens).\n* Other serious systemic diseases:\n* Severe liver dysfunction (Child-Pugh grade C or ALT\u002FAST \\> 3 times the upper limit of normal).\n* Active, uncontrolled severe infection.\n* Life expectancy is less than one year.\n* Special circumstances related to the research:\n* A kidney transplant is planned within the next six months.\n* Has participated in any other interventional clinical trials within the past 3 months.\n* Poor compliance and special populations:\n* There are mental or cognitive impairments, making it impossible to understand or cooperate with the research.\n* Pregnant or lactating women, or women of childbearing age who are unwilling to take effective contraceptive measures during the study period.","ALL","18 Years","80 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","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 patients' quality of life. The prevalence of sarcopenia in patients receiving maintenance hemodialysis (MHD) ranges from 32.7% to 73.5%, which is substantially higher than that in the general population (5% - 13%). Sarcopenia significantly elevates the mortality risk in MHD patients. Specifically, sarcopenia patients experience an increased all - cause mortality rate, a heightened risk of cardiovascular events, a decline in quality of life, and an augmented risk of falls and fractures. A close pathophysiological relationship exists between the hypoxia - inducible factor - 1 (HIF - 1) pathway and sarcopenia. HIF - 1α serves as a key transcription factor for cells to respond to hypoxic conditions. Under normoxic conditions, HIF - 1α is hydroxylated by prolyl hydroxylase (PHD) and subsequently undergoes ubiquitination - mediated degradation. Conversely, under hypoxic circumstances, HIF - 1α is stably expressed, translocates into the nucleus, and activates downstream target genes. HIF - 1α promotes the expression of genes associated with glycolysis, such as GLUT1 and LDHA, while inhibiting mitochondrial oxidative phosphorylation. This results in a shift of skeletal muscle energy metabolism from aerobic to anaerobic pathways. Research has revealed that the protein level of HIF - 1α is significantly decreased in sarcopenia patients. Roxadustat capsules, an oral medication, represent the world's first small - molecule hypoxia - inducible factor prolyl hydroxylase inhibitor (HIF - PHI) developed for the treatment of renal anemia. The physiological function of HIF - 1α not only enhances the expression of erythropoietin but also upregulates the expression of erythropoietin receptors and proteins involved in promoting iron absorption and circulation. Theoretically, roxadustat has the potential to improve sarcopenia. However, due to its prominent effect on anemia correction, it is currently only clinically applicable to anemic patients. This study aims to use ESA as a control to investigate the effect of roxadustat on sarcopenia in hemodialysis patients during the treatment of renal anemia.",[28,29,30],"Sarcopenia","Anemia Associated With Chronic Kidney Disease (CKD)","Dialysis Patients",[28,32],"Anemia","NOT_YET_RECRUITING","2025-09-07",{"date":36,"type":37},"2025-09-09","ACTUAL",{"date":39,"type":22},"2025-09-10",{"date":41,"type":22},"2026-12-31",{"name":43,"class":44},"Tianjin Medical University General Hospital","OTHER"]