Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves interviews with adult patients and parents of children suffering from Nephrotic Syndrome, focusing on their experiences with swelling and fluid overload. Conducted by researchers from the University of Michigan and Northwestern University, the study aims to gather qualitative data that will inform the development of a survey for evaluating new medications targeting Nephrotic Syndrome. The interviews will help create core outcome measures that reflect patient and observer perspectives on edema associated with the condition.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Eloise Salmon, M.D. — University of Michigan
• Study coordinator: Ashley Rahimi
• Email: asboggs@med.umich.edu
• Phone: 734-647-5446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NEPTUNE Match: Personalized matching of patients to kidney treatment options

  This project will try a system that matches people in the NEPTUNE cohort who have nephrotic syndromes or related kidney diseases with suitable clinical trials and shares those matches with patients and their doctors.

  Recruiting at 15 sites University of Michigan · Atlanta, Georgia and 15 other locations · NCT04571658

• A network for analyzing kidney biopsy data in glomerular diseases

  This study is trying to build a detailed database of kidney biopsy samples and health information from patients with glomerular diseases to help researchers better understand these conditions and improve treatments.

  Recruiting at 6 sites Seoul National University Hospital · Chuncheon and 5 other locations · NCT03929887

• Autoimmune podocytopathy and anti-nephrin antibodies

  This study tests whether children and adults with nephrotic syndrome have anti-nephrin autoantibodies and whether those antibodies relate to relapses and treatment response.

  Recruiting Meyer Children's Hospital IRCCS · Rochester, Minnesota and 13 other locations · NCT07516964

• Atacicept for multiple autoimmune glomerular diseases

  This will test whether weekly injections of atacicept can lower protein in the urine and help preserve kidney function in people aged 10 and older with IgA nephropathy, primary membranous nephropathy, or nephrotic syndromes such as MCD and FSGS.

  Recruiting Phase 2 Vera Therapeutics, Inc. · Brisbane, California · NCT06983028

• Testing ManNAc for treating kidney disease FSGS

  This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Observational study on kidney transplant recurrence in FSGS and MCD

  This study is looking at patients with kidney diseases called FSGS and MCD who have had or will have a kidney transplant to see how often these diseases come back afterward.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT05650619

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.