[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568863":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":53,"collaborators":29,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":29,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":29,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":29,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"low-dose LC-Z300-01","EXPERIMENTAL","Sugar cane polysaccharide LC-Z300-01: 0.5g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.",[13],"Dietary Supplement: Sugar cane polysaccharide",{"label":15,"type":10,"description":16,"interventionNames":17},"high-dose LC-Z300-01","Sugar cane polysaccharide LC-Z300-01: 1.0g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"control","PLACEBO_COMPARATOR","Identical placebo: 2 tablets, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.",[23],"Dietary Supplement: Control",[25,30],{"type":26,"name":27,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","Sugar cane polysaccharide",[15,9],null,{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Control","placebo",[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Lin Li, Dr.","CONTACT","+8613816275180","lilin_616@163.com",[41],{"facility":5,"status":29,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":29},"Shanghai","Shanghai Municipality","20003","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},{"type":54,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100568863","efficacy-and-safety-of-lc-z300-01-on-proteinuria-in-diabetic-patients-100568863",false,"NCT06686758","Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients","A Trial Investigating the Efficacy and Safety of LC-Z300-01 on Proteinuria in Patients With Diabetic Kidney Disease","Inclusion Criteria\n\n1. Age ≥18 years.\n2. Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.\n3. HbA1c ≤9% at screening.\n4. Elevated albuminuria defined as either: uACR ≥30 mg\u002Fg on ≥2 occasions within 3 months or sustained proteinuria \\>300 mg\u002F24-hour urine collection.\n5. eGFR ≥60 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation) at baseline.\n6. Stable RAS blockade therapy meeting either: Maximum tolerated dose of ACE inhibitor\u002FARB for ≥4 weeks pre-screening or documented intolerance to ACEi\u002FARB (with nephrologist confirmation).\n7. If using SGLT2 inhibitors and\u002For nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs): stable regimen ≥4 weeks pre-enrollment or commitment to maintain dosing throughout study.\n8. Capacity to provide written informed consent (self or via legally authorized representative).\n\nExclusion Criteria\n\n1. Type 1 diabetes or secondary diabetes.\n2. Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.\n3. Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).\n4. Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).\n5. patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.\n6. patients with a history of malignancy within 5 years.\n7. participation in other clinical studies within 3 months.\n8. Pregnant or lactating women.\n9. hypersensitivity to any of the components of the interventions in this study.\n10. alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.","ALL","18 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"NA","The purpose of this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD).",[72],"Diabetic Kidney Disease","NOT_YET_RECRUITING","2025-03-28",{"date":76,"type":77},"2025-04-02","ACTUAL",{"date":79,"type":66},"2025-04",{"date":81,"type":66},"2026-05",{"name":5,"class":6},1]