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

Fluid Overload Clinical Trial

— Prepare-NS  

Official title:

Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505500
• Other study ID #: HUM00208148
• Secondary ID: 5UG3FD007308-02
• Status: Recruiting
• Start date: April 18, 2022
• Est. completion date: April 2026

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Tina Creguer
• Phone: 734-936-3590
• Email: tcreguer[@]umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Edema
• Fluid Overload
• FSGS
• Glomerular Disease
• Glomerulonephritis, Membranous
• Glomerulosclerosis, Focal Segmental
• Kidney Diseases
• Membranous Nephropathy
• Minimal Change Disease
• Minimal Change Nephrotic Syndrome
• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Nephrotic Syndrome in Children
• Nephrotic Syndrome, Minimal Change
• Syndrome

Intervention

Behavioral:
• Interview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Food and Drug Administration (FDA), Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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