Nephrotic Syndrome Study Network

This observational study aims to better understand kidney diseases like Minimal Change Disease (MCD), Membranous Nephropathy, and Focal Segmental Glomerulosclerosis (FSGS). These conditions can lead to serious kidney problems, and current treatments often have side effects and aren't always effective. Researchers are looking at how these diseases change over time by tracking kidney function and protein in your urine. If you are scheduled for a kidney biopsy, you might be asked to provide an additional tissue sample for this study. The goal is to improve our understanding of these diseases so better treatments can be developed in the future. This study is open to people of all genders, from birth to 80 years old, who have certain levels of protein in their urine.

Study design
This is an observational study with a planned enrollment of 1200 participants. It is not testing a specific drug or treatment.
What's involved
If you are having a kidney biopsy, you may be asked to provide an additional tissue sample. Your kidney function and urinary protein levels will be tracked for 60 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 60 months to measure changes in urinary protein excretion and kidney function.

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NCT01209000

Nephrotic Syndrome Study Network

Recruiting
Not specifiedUp to 80Observational
University of Michigan
~1,200 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Kidney Biopsy

At a glance

Recruiting sites
33 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event rate of change in urinary protein excretion and renal function.
Measured over 60 months
+1 more outcome measured
Minimal Change Disease (MCD)
Membranous Nephropathy
Glomerulosclerosis, Focal Segmental
44 sites across 18 states
New York6
Ontario5
California4
Ohio4
North Carolina3
Pennsylvania3
Washington3
Colorado2
  • Matthias Kretzler, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

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
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

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)
  • Event rate of change in urinary protein excretion and renal function.60 months

    Defined as remission, partial remission and non-remission

  • Rate of change in renal function.60 months

    Defined as: 1. 25 mls/min/1.73m2 reduction in follow-up estimated GFR (using the 4-variable MDRD equation for ages ≥18 years and modified Schwartz for ages \<18 years) compared to baseline estimated GFR 2. 50% decline in follow-up estimated GFR compared to baseline measurement 3. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or preemptive kidney transplantation.