Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
Key facts
- Who runs it
- University of Michigan
- Where
- Ann Arbor, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 18 Apr 2022
- Planned end
- 30 Apr 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Interview
- Record updated
- 22 December 2025
Who can take part
- Age
- 2 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Parents/guardians must be able to read and understand English
- Parents/guardians 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
- The child must have a current NS-associated edema
- The child must have native kidney function
- Parents/guardians must provide informed consent
- ≥8 years of age
- Able to read and understand English
- Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease; Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied
- Current NS-associated edema
- Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) > 25 ml/min/1.73m2
- Informed Consent: For patients ≥8 to <18 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
Who cannot take part
- Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
- 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
- Index case with dialysis dependence throughout the 3-month pre-enrollment period; Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
Other criteria
- Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Ashley RahimiTaking people
About the trial
What the trial wants to find out
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.
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Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.
The 2 groups in the trial
- Parent/Guardian of child with Nephrotic Syndrome (NS)
This group will help create the Observer Reported Outcome (ObsRO) tool.
Treatment: Interview
- Person with Nephrotic Syndrome (NS)
This group will help create the Patient Reported Outcome (PRO) tool.
Treatment: Interview
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
- Record updated
- 22 December 2025