Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05505500

Conditions

Fluid Overload

Glomerulosclerosis, Focal Segmental

Edema

Membranous Nephropathy

Minimal Change Disease

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Interview

Study Details

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

Study ID

NCT05505500

Start date

Apr 18, 2022

Status verified date

Nov, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:

Inclusion Criteria:

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.

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:

Inclusion Criteria:

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:

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Parent/Guardian of child with Nephrotic Syndrome (NS)

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

Person with Nephrotic Syndrome (NS)

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

Interventions

Interview

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

Primary outcome measure

  • Patient Reported Impact of Fluid Overload on symptoms and functioning [ Time Frame: Interviews are 60 minutes ]
  • Observer Reported Impact of Fluid Overload on symptoms and functioning [ Time Frame: Interviews are 60 minutes ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Eloise Salmon, M.D.

More Information

Sponsor

University of Michigan

Last update posted

Dec 22, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-22.