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

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05505500

Run by

University of Michigan

People needed

150

Starts

2022-04-18

Expected to finish

2026-04-30

Last updated by the study team

2025-12-22

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Inclusion Criteria:
• ≥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.
• Exclusion Criteria:
• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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