NCT05505500 Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
| NCT ID | NCT05505500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Fluid Overload |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-04-18 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Eloise Salmon, M.D.
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05505500 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Fluid Overload. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05505500 currently recruiting?
Yes, NCT05505500 is actively recruiting participants. Contact the research team at asboggs@med.umich.edu for enrollment information.
Where is the NCT05505500 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05505500 clinical trial?
NCT05505500 is sponsored by University of Michigan. The principal investigator is Eloise Salmon, M.D. at University of Michigan. The trial plans to enroll 150 participants.