Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
NCT ID: NCT05505500
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2022-04-18
2026-04-30
Brief Summary
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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.
Detailed Description
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The 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parent/Guardian of child with Nephrotic Syndrome (NS)
This group will help create the Observer Reported Outcome (ObsRO) tool.
Interview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Person with Nephrotic Syndrome (NS)
This group will help create the Patient Reported Outcome (PRO) tool.
Interview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Interventions
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Interview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. The child must have a current NS-associated edema
4. The child must have native kidney function
5. Parents/guardians must provide informed consent.
1. ≥8 years of age
2. Able to read and understand English
3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.
i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied
4. Current NS-associated edema
5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \> 25 ml/min/1.73m2
6. 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.
Exclusion Criteria
Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
2. 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
2 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Food and Drug Administration (FDA)
FED
University of Michigan
OTHER
Responsible Party
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Eloise Salmon
Assistant Professor of Pediatrics, Division of Nephrology
Principal Investigators
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Eloise Salmon, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
John Peipert, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Rahimi
Role: primary
Other Identifiers
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HUM00208148
Identifier Type: -
Identifier Source: org_study_id