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

ConditionsFluid 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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age2+

SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

≥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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Parent/Guardian of child with Nephrotic Syndrome (NS)1 intervention

Group B: Person with Nephrotic Syndrome (NS)1 intervention

Trial outcomes

Primary outcomes

Patient Reported Impact of Fluid Overload on symptoms and functioning

Themes generated through qualitative analysis from semi-structured interviews

Time frame

Interviews are 60 minutes

Observer Reported Impact of Fluid Overload on symptoms and functioning

Themes generated through qualitative analysis from semi-structured interviews

Time frame

Interviews are 60 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Northwestern University

Collaborator

Food and Drug Administration (FDA)

Collaborator

Source ClinicalTrials.gov

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