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
Who can join
Ages 2 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Interview (behavioral)
Sponsor: University of Michigan · Participants: 150 · Started: Apr 18, 2022
Contact the study team
- Ashley Rahimi · Phone: 734-647-5446
Official record on ClinicalTrials.gov — NCT05505500
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
Conditions
- Edema
- Focal Segmental Glomerulosclerosis
- Membranous Glomerulonephritis
- Lipoid Nephrosis
- Nephrotic Syndrome
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.