[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05505500":3,"trial-entities:NCT05505500":94,"trial-summary:NCT05505500":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":32,"study_type":35,"primary_purpose":15,"phases":36,"enrollment_info":37,"interventions":40,"primary_outcomes":48,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":15,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":67,"central_contacts":85,"overall_officials":87,"references":92,"see_also_links":93},"NCT05505500","HUM00208148","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","RECRUITING","2026-04-30","2025-11","2025-12-22","2022-04-18","University of Michigan","OTHER",null,"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.","This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema\u002Ffluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release.\n\nThe researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.",[19,20,21,22,23,24,25,26,27,28,29,30,31],"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",[26,33,34,19,21,31,23,22,25],"Child","Adult","OBSERVATIONAL",[],{"count":38,"type":39},150,"ESTIMATED",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45},"BEHAVIORAL","Interview","Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.",[46,47],"Parent\u002FGuardian of child with Nephrotic Syndrome (NS)","Person with Nephrotic Syndrome (NS)",[49,53],{"measure":50,"description":51,"timeFrame":52},"Patient Reported Impact of Fluid Overload on symptoms and functioning","Themes generated through qualitative analysis from semi-structured interviews","Interviews are 60 minutes",{"measure":54,"description":51,"timeFrame":52},"Observer Reported Impact of Fluid Overload on symptoms and functioning",[],"ALL","2 Years",false,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"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",[64,65,66],"CHILD","ADULT","OLDER_ADULT",[68],{"facility":13,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"Ann Arbor","Michigan","48109","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Ashley Rahimi","CONTACT","734-647-5446","asboggs@med.umich.edu",{"name":80,"role":81},"Eloise Salmon, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},42.27756,-83.74088,[86],{"name":75,"role":76,"phone":77,"email":78},[88,89],{"name":80,"affiliation":13,"role":81},{"name":90,"affiliation":91,"role":81},"John Peipert, Ph.D.","Northwestern University",[],[],{"nct_id":4,"conditions":95,"biomarkers":100},[96,97,98,99,26],"Focal Segmental Glomerulosclerosis","IgM nephropathy","Membranous Glomerulonephritis","Minimal Change Glomerulonephritis",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study involving interviews. It aims to enroll 150 participants.","completed","Interview Study for Nephrotic Syndrome Swelling","This study is looking for adults and children with swelling (edema) from Nephrotic Syndrome, as well as parents of young children with this condition. Researchers want to understand your experiences with swelling. You would participate in a 1-hour interview. The information gathered will help create new surveys to measure how well future medications for Nephrotic Syndrome work. The goal is to develop tools that can be used in drug development to better understand the impact of fluid overload. This is an observational study, meaning no new treatments are being tested. The study aims to enroll 150 participants, but its current recruitment status is unclear.","Not specified.",104,"You would participate in a 1-hour interview to discuss experiences with swelling.","Not stated in the trial record.",[43],"v2"]