Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephroti… (NCT05505500) | Clinical Trial Compass
RecruitingNot Applicable
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
United States150 participantsStarted 2022-04-18
Plain-language 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.
Who can participate
Age range2 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. ≥8 years of age
✕. Able to read and understand English
✕. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.
✕. Current NS-associated edema
What they're measuring
1
Patient Reported Impact of Fluid Overload on symptoms and functioning
Timeframe: Interviews are 60 minutes
2
Observer Reported Impact of Fluid Overload on symptoms and functioning
✕. 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