Nephrotic Syndrome Study Network

What this study is about

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients. In response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium. Through this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.

Who can join (things the study team will check)

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

🚫 You may not be able to join if…

• 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

• University of Southern California-Children's Hospital, Los Angeles, California, United States
• Stanford University School of Medicine, Palo Alto, California, United States
• University of California San Francisco Benioff Children's Hospitals, San Francisco, California, United States
• Lundquist Biomedical Research Institute at Harbor UCLA Medical Center, Torrance, California, United States
• Children's Hospital Colorado, Aurora, Colorado, United States
• University of Colorado Anschutz School of Medicine, Aurora, Colorado, United States
• University of Miami Miller School of Medicine, Miami, Florida, United States
• Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
• John Stroger Cook County Hospital, Chicago, Illinois, United States
• University of Kansas Medical Center, Kansas City, Kansas, United States
• Johns Hopkins Medical Institute, Baltimore, Maryland, United States
• Kidney Disease Section, NIDDK, NIH, Bethesda, Maryland, United States

+ 32 more sites.

Who to contact

Chrysta C. Lienczewski, BS · 734-615-5021 · NEPTUNE-Study@umich.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT01209000.