Fluid Overload Clinical Trial
— Prepare-NSOfficial title:
Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility | 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 or history of NS-associated edema within the past 3 months; 4. The child may have native kidney function or may be kidney transplant dependent with a history of post-transplant NS recurrence; 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 ii. Kidney disease in the native kidneys or recurrent in kidney transplant 4. Current or history of NS-associated edema within the past 3 months 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 OR kidney transplant recipient with ongoing dialysis therapy at the time of enrollment. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Food and Drug Administration (FDA), Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Reported Impact of Fluid Overload on symptoms and functioning | Themes generated through qualitative analysis from semi-structured interviews | Interviews are 60 minutes | |
Primary | Observer Reported Impact of Fluid Overload on symptoms and functioning | Themes generated through qualitative analysis from semi-structured interviews | Interviews are 60 minutes |
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