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โ† Trials
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Nephrotic Syndrome Study Network

Recruitingn/aAges any - 80 YearsAllUniversity of Michigan
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ1500 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)
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What it tests

  • Kidney Biopsy
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Where

44 sites
University of Southern California-Children's Hospital
Los Angeles, United States
Stanford University School of Medicine
Palo Alto, United States
University of California San Francisco Benioff Children's Hospitals
San Francisco, United States
Lundquist Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, United States
Children's Hospital Colorado
Aurora, United States
University of Colorado Anschutz School of Medicine
Aurora, United States
University of Miami Miller School of Medicine
Miami, United States
Emory University and Children's Healthcare of Atlanta
Atlanta, United States

โ€ฆand 36 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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