Edema, Fluid Overload, FSGS, Glomerular Disease, Glomerulosclerosis, Focal Segmental, IgM Nephropathy, Membranous Nephropathy, Minimal Change Disease, Minimal Change Nephrotic Syndrome, Nephrotic Syndrome, Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change, Nephrotic Syndrome With Edema (Diagnosis)
Conditions
Keywords
Nephrotic Syndrome, Child, Adult, Fluid Overload, Edema, FSGS, Minimal Change Disease, Membranous Nephropathy, IgM Nephropathy
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.
Detailed description
This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release. The researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.
Interventions
BEHAVIORALInterview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Sponsors
Northwestern University
Food and Drug Administration (FDA)
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Impact of Fluid Overload on symptoms and functioning | Interviews are 60 minutes | Themes generated through qualitative analysis from semi-structured interviews |
| Observer Reported Impact of Fluid Overload on symptoms and functioning | Interviews are 60 minutes | Themes generated through qualitative analysis from semi-structured interviews |
Countries
United States
Contacts
Primary ContactAshley Rahimi
Outcome results
None listed