Observational study on nephrotic syndrome and its causes

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 focuses on understanding the biology and treatment of nephrotic syndrome, specifically Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS), and Membranous Nephropathy (MN). It aims to address the inadequacies in the current clinical classification and treatment strategies for these conditions, which significantly contribute to end-stage renal disease. The study involves kidney biopsies to better classify and understand the disease mechanisms, with the goal of improving patient outcomes and reducing the financial burden associated with these diseases.

Why it matters

Who can join: the full rules

Cohort A (biopsy cohort) Inclusion Criteria:

Patients presenting with an incipient clinical diagnosis for FSGS/MCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS/MCD or MN meeting the following inclusion criteria:

* Documented urinary protein excretion ≥1500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.
* Scheduled renal biopsy

Cohort B (non-biopsy, cNEPTUNE) Inclusion Criteria:

* Age \<19 years of age
* Initial presentation with \<30 days immunosuppression therapy
* Proteinuria/nephrotic

  * UA\>2+ and edema OR
  * UA\>2+ and serum albumin \<3 OR
  * UPC \> 2g/g and serum albumin \<3

Exclusion Criteria (Cohort A\&B):

* Prior solid organ transplant
* A clinical diagnosis of glomerulopathy without diagnostic renal biopsy
* Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)
* Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)
* Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months
* Unwillingness or inability to give a comprehensive informed consent
* Unwillingness to comply with study procedures and visit schedule
* Institutionalized individuals (e.g., prisoners)

Where it's running

• University of Southern California-Children's Hospital
  Los Angeles, California, United States Recruiting
• Stanford University School of Medicine
  Palo Alto, California, United States Recruiting
• Lundquist Biomedical Research Institute at Harbor UCLA Medical Center
  Torrance, California, United States Recruiting
• University of Miami Miller School of Medicine
  Miami, Florida, United States Recruiting
• Emory University and Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• John Stroger Cook County Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Matthias Kretzler, MD — University of Michigan
• Study coordinator: Chrysta C. Lienczewski, BS
• Email: NEPTUNE-Study@umich.edu
• Phone: 734-615-5021

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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.