Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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.

• ≥8 years of age

• Able to read and understand English

• 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

• Current NS-associated edema

• 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Ashley Rahimi
asboggs@med.umich.edu
734-647-5446
Time Frame
Start Date: 2022-04-18
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 150
Treatments
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.
Sponsors
Collaborators: Northwestern University, Food and Drug Administration (FDA)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov