Fluid OverloadPrepare-NSNCT05505500
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
An observational study of Fluid Overload and Glomerulosclerosis, Focal Segmental, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Fluid Overload, Glomerulosclerosis, Focal Segmental, Edema
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 30 Apr 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ObsRO Study Population: Data collection will involve approximately 20-40 parents/guardians of children ages 2-11.999 with NS PRO Study Population: Data collection will involve N = 60 to 95 patients ≥8 years of age with NS (depending on when concept saturation is achieved; see section 9.0 Statistical Considerations for more detail). Recruitment of patients with NS will occur across the United States. Enrollment will take place at the University of Michigan.
Who may be able to join
- 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
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- Able to read and understand English
- Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.
- 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.
Who cannot join
- 1. Index case with dialysis dependence throughout the 3-month pre-enrollment period
- Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
- Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Ashley Rahimi, 734-647-5446, asboggs@med.umich.edu
Eloise Salmon, M.D.
About this study
Official 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.
Read the detailed description
This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release.
The researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.
- Conditions
- Fluid Overload, Glomerulosclerosis, Focal Segmental, Edema, Membranous Nephropathy, Minimal Change Disease, Minimal Change Nephrotic Syndrome
- Being tested
- Interview
- Keywords
- Nephrotic Syndrome, Child, Adult, Fluid Overload, Edema, FSGS, Minimal Change Disease, Membranous Nephropathy, IgM Nephropathy
- Medical subject headings
- Edema, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous, Nephrosis, Lipoid, Nephrotic Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
| Study group | Role | What they receive |
|---|---|---|
| Parent/Guardian of child with Nephrotic Syndrome (NS) | This group will help create the Observer Reported Outcome (ObsRO) tool. Receives: Behavioral: Interview | |
| Person with Nephrotic Syndrome (NS) | This group will help create the Patient Reported Outcome (PRO) tool. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Impact of Fluid Overload on symptoms and functioning
Themes generated through qualitative analysis from semi-structured interviews
Measured: Interviews are 60 minutes
Observer Reported Impact of Fluid Overload on symptoms and functioning
Themes generated through qualitative analysis from semi-structured interviews
Measured: Interviews are 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start18 Apr 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Eloise Salmon, University of Michigan
- Investigators
- Eloise Salmon, M.D., Principal investigator, University of MichiganJohn Peipert, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505500
- Sponsor's protocol ID
- HUM00208148
- Other IDs
- 5UG3FD007308-02
- Acronym
- Prepare-NS
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No