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New study aims to measure swelling in kidney disease patients

NCT ID NCT05505500

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

Researchers at the University of Michigan and Northwestern University are interviewing children, adults, and parents of young children about their experiences with swelling caused by Nephrotic Syndrome. The goal is to develop a survey that can be used in future clinical trials to test new medications. This study does not test any treatment but focuses on understanding symptoms to improve how drug effectiveness is measured.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study will create a better survey to measure swelling in future Nephrotic Syndrome drug trials, helping researchers know if new treatments work.
What could go wrong
This is an early-stage interview study, not a treatment trial. The survey may not capture all patient experiences or may not be used in future trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease Edema focal segmental glomerulosclerosis glomerular disorder lipoid nephrosis membranous glomerulonephritis nephrotic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Edema Fluid overload FSGS Glomerular disease Glomerulosclerosis, focal segmental IgM nephropathy Membranous nephropathy Minimal change disease Minimal change nephrotic syndrome Nephrotic syndrome Nephrotic syndrome in children Nephrotic syndrome with edema (diagnosis) Nephrotic syndrome, minimal change

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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