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

NCT05505500 | Recruiting

• 2 other identifiers: HUM002081485UG3FD007308-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Nephrotic Syndrome; Child; Adult; Fluid Overload; Edema; FSGS; Minimal Change Disease; Membranous Nephropathy; IgM Nephropathy

Outcome Measures

Primary Outcomes (2)

• Patient Reported Impact of Fluid Overload on symptoms and functioning

  Themes generated through qualitative analysis from semi-structured interviews

  Interviews are 60 minutes

• Observer Reported Impact of Fluid Overload on symptoms and functioning

  Themes generated through qualitative analysis from semi-structured interviews

  Interviews are 60 minutes

Study Arms (2)

Parent/Guardian of child with Nephrotic Syndrome (NS)

This group will help create the Observer Reported Outcome (ObsRO) tool.

Behavioral: Interview

Person with Nephrotic Syndrome (NS)

This group will help create the Patient Reported Outcome (PRO) tool.

Behavioral: Interview

Interventions

Interview BEHAVIORAL

Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.

Parent/Guardian of child with Nephrotic Syndrome (NS); Person with Nephrotic Syndrome (NS)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ObsRO Study Population: Data collection will involve approximately 20-40 parents/guardians of children ages 2-11.999 with NS PRO Study Population: Data collection will involve N = 60 to 95 patients ≥8 years of age with NS (depending on when concept saturation is achieved; see section 9.0 Statistical Considerations for more detail). Recruitment of patients with NS will occur across the United States. Enrollment will take place at the University of Michigan.

You may qualify if:

• 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.

You may not qualify if:

• \. Index case with dialysis dependence throughout the 3-month pre-enrollment period
• Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
• ≥8 years of age
• Able to read and understand English
• 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
• 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.
• 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

Sponsors & Collaborators

• University of Michigan: lead
• Northwestern University: collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Edema; Glomerulosclerosis, Focal Segmental; Glomerulonephritis, Membranous; Nephrosis, Lipoid; Nephrotic Syndrome; Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Nephrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eloise Salmon, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• John Peipert, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Rahimi

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Division of Nephrology

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: April 18, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)