[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494338":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":63,"collaborators":65,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Military Institute od Medicine National Research Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"KA+MPD","EXPERIMENTAL","Ketosteril + Medium Protein Diet (MPD) for 12 months",[13,14],"Drug: Ketosteril","Other: Medium Protein Diet (MPD)",{"label":16,"type":17,"description":18,"interventionNames":19},"MPD","ACTIVE_COMPARATOR","Medium Protein Diet (MPD) for 12 months",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ketosteril","Daily dose = 1 tabl \u002F 5 kg of ideal body weight",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Medium Protein Diet (MPD)","MPD: daily protein intake of 0.8-1.0 g\u002Fkg of ideal body weight + up to 5 g based on daily proteinuria",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Anna Matyjek","Military Institute of Medicine National Research Institute","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Anna Matyjek, MD, PhD","CONTACT","261817045","+48","amatyjek@wim.mil.pl",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute","RECRUITING","Warsaw","Masovian District","04-141","Poland","PL",{"type":53,"coordinates":54},"Point",[55,56],21.01178,52.22977,{"lat":56,"lon":55},[59,60],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":61,"role":62,"phone":26,"phoneExt":26,"email":26},"Stanislaw Niemczyk, MD, PhD, Prof.","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[66,68],{"name":67,"class":6},"Medical University of Lodz",{"name":69,"class":6},"Medical University of Warsaw","100494338","phase-3-ketoanalogues-for-muscle-mass-loss-in-nephrotic-syndrome-100494338",false,"NCT05716880","Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome","FORMA - a Multicenter Randomized-controlled Trial to Evaluate the Efficacy and Safety of Ketoanalogues of Essential Amino Acids in Prophylaxis of Protein-energy Wasting in Nephrotic Syndrome","FORMA","Inclusion Criteria:\n\n* Nephrotic syndrome with serum albumin \\\u003C 3.0 g\u002FdL and daily proteinuria of \\> 3.5 g\u002Fday or \\> 50 mg\u002Fkg;\n* New diagnosis or relapse of nephrotic syndrome (defined as: proteinuria of \\\u003C 2.0 g\u002Fday or uPCR \\\u003C 2000 mg\u002Fg in the last 6 months prior to relapse and prednison dose equal to or less than 10 mg\u002Fday in the last 3 months prior relapse);\n* Glomerular filtration rate qual to or higher than 30 mL\u002Fmin\u002F1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n\nExclusion Criteria:\n\n* Diabetic kidney disease;\n* Small vessels vasculitis;\n* Systemic lupus erythematosus;\n* Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA);\n* Positive anti-HIV or anti-hepatitis C antibodies, HBsAg;\n* HbA1c \\>7%;\n* Monoclonal gammopathy;\n* Pregnancy;\n* Body mass index \\>= 40 kg\u002Fm2;\n* Severe acute or chronic disease affecting nutritional status;\n* Neoplasm;\n* Contraindication to Ketosteril;\n* Alcohol or drug abuse;\n* Mental disorders;\n* Failure to comply with medical recommendations, lack of cooperation;\n* Participation in other clinical trial or the use of Ketosteril in the last 1 year prior to screening.","ALL","18 Years",{"count":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","The goal of this non-commercial clinical trial is to assess efficacy and safety of ketoanalogues of essential amino acids in the prevention of protein-energy wasting in nephrotic syndrome.",[88],"Nephrotic Syndrome",[90,91,92,93,23,94],"nephrotic syndrome","protein-energy wasting","neph-PEW","lean tissue mass","ketoanalogues","2023-01-30",{"date":97,"type":98},"2023-02-08","ACTUAL",{"date":100,"type":98},"2023-01-03",{"date":102,"type":82},"2027-08-31",{"name":5,"class":6},1]