[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478094":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":57,"id":62,"slug":10,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":90,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Parent\u002FGuardian of child with Nephrotic Syndrome (NS)",null,"This group will help create the Observer Reported Outcome (ObsRO) tool.",[13],"Behavioral: Interview",{"label":15,"type":10,"description":16,"interventionNames":17},"Person with Nephrotic Syndrome (NS)","This group will help create the Patient Reported Outcome (PRO) tool.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BEHAVIORAL","Interview","Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.",[9,15],[25,28],{"name":26,"affiliation":5,"role":27},"Eloise Salmon, M.D.","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"John Peipert, Ph.D.","Northwestern University",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Ashley Rahimi","CONTACT","734-647-5446","asboggs@med.umich.edu",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-83.74088,42.27756,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":27,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Eloise Salmon","Assistant Professor of Pediatrics, Division of Nephrology",[58,59],{"name":30,"class":6},{"name":60,"class":61},"Food and Drug Administration (FDA)","FED","100478094",false,"NCT05505500","Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.","Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome","Prepare-NS","Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:\n\nInclusion Criteria:\n\n1. Parents\u002Fguardians must be able to read and understand English;\n2. Parents\u002Fguardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;\n3. The child must have a current NS-associated edema\n4. The child must have native kidney function\n5. Parents\u002Fguardians must provide informed consent.\n\nExclusion Criteria:\n\n1\\. Index case with dialysis dependence throughout the 3-month pre-enrollment period\n\nCriteria for the Patient Reported Outcomes (PRO) cohort of the study:\n\nInclusion Criteria:\n\n1. ≥8 years of age\n2. Able to read and understand English\n3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.\n\n   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied\n4. Current NS-associated edema\n5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \\> 25 ml\u002Fmin\u002F1.73m2\n6. Informed Consent: For patients ≥8 to \\\u003C18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.\n\nExclusion Criteria:\n\n1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period\n2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS","ALL","2 Years",{"count":72,"type":73},150,"ESTIMATED","OBSERVATIONAL","Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.\n\nPlease consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.",[77,78,79,80,81,82,83,84,85,86,87,88,89],"Fluid Overload","Glomerulosclerosis, Focal Segmental","Edema","Membranous Nephropathy","Minimal Change Disease","Minimal Change Nephrotic Syndrome","IgM Nephropathy","Nephrotic Syndrome","Glomerular Disease","Nephrotic Syndrome, Minimal Change","Nephrotic Syndrome in Children","Nephrotic Syndrome With Edema (Diagnosis)","FSGS",[84,91,92,77,79,89,81,80,83],"Child","Adult","2025-12-15",{"date":95,"type":96},"2025-12-22","ACTUAL",{"date":98,"type":96},"2022-04-18",{"date":100,"type":73},"2026-04-30",{"name":5,"class":6},1]