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

Launched by UNIVERSITY OF MICHIGAN · Aug 16, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the experiences of patients, both adults and children, as well as their parents, who are dealing with swelling caused by a condition known as Nephrotic Syndrome. Researchers from the University of Michigan and Northwestern University will conduct interviews to gather information about how this swelling affects daily life. The insights gained will help them create a survey that can be used in future studies to test new medications for this condition.

If you or your child has Nephrotic Syndrome and is between the ages of 2 and 11, you may be eligible to participate. To join, parents or guardians must be able to read and understand English, and the child must currently have swelling related to their condition and have healthy kidney function. The interview will take about an hour, and it’s a chance to share your experiences which can help improve treatments for others in the future. Participation is completely voluntary, and informed consent will be required.

Gender

ALL

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