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RECRUITING

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

NCT05505500•University of Michigan

Summary

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. 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

This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid 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. 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.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:
•1. Parents/guardians must be able to read and understand English;
•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
+3 more criteria

Exclusion Criteria

•1\. Index case with dialysis dependence throughout the 3-month pre-enrollment period
•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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

April 18, 2022

Primary Completion Date

April 30, 2026

Completion Date

April 30, 2026

Last Updated

December 22, 2025

Enrollment

150

ESTIMATED participants

Conditions

Fluid OverloadGlomerulosclerosis, Focal SegmentalEdemaMembranous NephropathyMinimal Change DiseaseMinimal Change Nephrotic SyndromeIgM NephropathyNephrotic SyndromeGlomerular DiseaseNephrotic Syndrome, Minimal ChangeNephrotic Syndrome in ChildrenNephrotic Syndrome With Edema (Diagnosis)FSGS

Interventions

Interview

BEHAVIORAL

Contacts

Ashley Rahimi

CONTACT

734-647-5446 asboggs@med.umich.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Inclusion Criteria

Exclusion Criteria

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