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Observational study on nephrotic syndrome and its causes

Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

Observational University of Michigan · NCT01209000

This study is trying to learn more about nephrotic syndrome and its different types to improve how we treat it and help patients feel better.

Quick facts

Study typeObservational
Enrollment1200 (estimated)
AgesN/A to 80 Years
SexAll
SponsorUniversity of Michigan Academic / other
Drugs / interventionscyclophosphamide
Locations44 sites (Los Angeles, California and 43 other locations)
Trial IDNCT01209000 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with a clinical diagnosis of FSGS, MCD, or MN who are scheduled for a renal biopsy.

Not a fit: Patients with prior solid organ transplants or those with a clinical diagnosis of glomerulopathy without a diagnostic renal biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and targeted treatments for patients with nephrotic syndrome.

How similar studies have performed: Other studies have shown promise in understanding nephrotic syndrome, but this approach aims to fill significant gaps in knowledge and treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Los Angeles, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Minimal Change DiseaseMembranous NephropathyGlomerulosclerosis, Focal SegmentalFocal and Segmental GlomerulosclerosisFocal & Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisFSGSMinimal change disease
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.