[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541419":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":26,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","In the intervention group, low-protein diet (0.6-0.8g protein\u002Fkg body weight\u002Fday) and Ketosteril 0.12 g\u002Fkg body weight\u002Fday will be prescribed with the target energy intake of 25-30kcal\u002Fkg body weight\u002Fday. The intervention will last for 6 months. Then,during the subsequent 3-month observation period, the patients maintain a low-protein diet (0.6-0.8g protein\u002Fkg body weight\u002Fday) with the target energy intake of 25-30kcal\u002Fkg body weight\u002Fday.",[13],"Combination Product: low-protein diet + Ketosteril",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","In the control group, low-protein diet (0.6-0.8g protein\u002Fkg body weight\u002Fday) and the target energy intake of 25-30kcal\u002Fkg body weight\u002Fday will be prescribed for 9 months",[19],"Dietary Supplement: low-protein diet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","low-protein diet + Ketosteril","low-protein diet (0.6-0.8g protein\u002Fkg body weight\u002Fday) and Ketosteril 0.12 g\u002Fkg body weight\u002Fday will be prescribed with the target energy intake of 25-30kcal\u002Fkg body weight\u002Fday.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DIETARY_SUPPLEMENT","low-protein diet","low-protein diet (0.6-0.8g protein\u002Fkg body weight\u002Fday) with the target energy intake of 25-30kcal\u002Fkg body weight\u002Fday.",[15],[33],{"name":34,"affiliation":5,"role":35},"Jing Chen, PhD, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mengjing Wang, PhD, MD","CONTACT","02152889393","fiyona27@126.com",[43],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Huashan hospital, Fudan university","RECRUITING","Shanghai","200040","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":58,"phoneExt":26,"email":41},"021-52889393",{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Chen Jing","Director of Nephrology","100541419","phase-3-effect-of-ketosteril-on-sarcopenia-in-patients-with-chronic-kidney-disease-100541419",false,"NCT06329622","Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease","Ketosteril Sarcopenia Chronic Kidney Disease","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR\\\u003C60 ml\u002F(min\\*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.\n2. Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (\\\u003C 28 kg for males, \\\u003C 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (\\\u003C 1.0 m\u002Fs) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (\\\u003C 7.0 kg\u002Fm2 for males and \\\u003C 5.7 kg\u002Fm2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.\n3. Patient can walk normally.\n4. Provide the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with diabetes.\n2. Obese\u002Foverweight patients (body mass index\\>25 kg\u002Fm2)\n3. Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).\n4. Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.\n5. Patients with acute infection (C-reactive protein\\>10 mg\u002FL) or acute exacerbation of chronic diseases that is not under control within 3 months.\n6. Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.\n7. Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.\n8. Patients with hypercalcemia and amino acid metabolism disorder.\n9. Those who are allergic to the active ingredients or other excipients of the Ketosteril.\n10. Patients with poor compliance, unable to follow the study requirements for diet control.\n11. Participated in other interventional clinical trials within 30 days before this study.","ALL",{"count":71,"type":72},58,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.",[78,79],"Chronic Kidney Disease","Sarcopenia",[81,82],"CKD","sarcopenia","2026-07-25",{"date":85,"type":86},"2026-07-28","ACTUAL",{"date":88,"type":86},"2024-05-01",{"date":90,"type":72},"2028-06-30",{"name":5,"class":6},1]