Actively Recruiting
Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
Led by University of Michigan · Updated on 2025-12-22
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers from the University of Michigan and Northwestern University are studying experiences of swelling caused by Nephrotic Syndrome in both children and adults. This observational study aims to gather detailed information from interviews with patients and parents to help develop new survey tools that assess fluid overload symptoms and impacts. The goal is to create core outcome measures that can be used in drug development focused on edema in Nephrotic Syndrome. Participants will take part in one-hour concept elicitation interviews to share their experiences with swelling related to Nephrotic Syndrome. There are two groups involved: one helping to create an Observer Reported Outcome (ObsRO) tool based on parents' observations, and another helping to develop a Patient Reported Outcome (PRO) tool based on patient self-reporting. This study involves gathering information only, with no experimental treatments. During the study, participants will complete interviews lasting about 60 minutes, where they discuss the impact of fluid overload on symptoms and daily functioning. Researchers will analyze these discussions to build validated survey tools that can measure patients' and observers' perspectives of edema. Participation involves sharing experiences through interviews, and the study aims to better understand swelling effects to support future medication testing. The study continues until April 2026.
CONDITIONS
Brief Title
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents or guardians able to read and understand English caring for a child aged 2 to under 12 years with medically documented primary Nephrotic Syndrome or related kidney disease
- Child must have current NS-associated swelling (edema) and native kidney function
- Parent or guardian must provide informed consent
- Patients aged 8 years or older able to read and understand English with primary Nephrotic Syndrome or related kidney disease
- Patients must have current NS-associated swelling (edema) and kidney function with recent eGFR over 25 ml/min/1.73m2
- Informed consent required; for patients aged 8 to under 18 years, parent/guardian consent and patient assent are needed; patients 18 years or older must consent themselves
You will not qualify if you...
- Child or patient with dialysis dependence during the 3 months before enrollment
- Co-existing significant chronic or severe acute health condition that may affect symptoms or functioning related to fluid overload in Nephrotic Syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - One-time session
Participants take part in interviews to help create and review tools measuring fluid overload symptoms and functioning.
1 visit (in-person or virtual)
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Ashley Rahimi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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