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RECRUITINGOBSERVATIONAL

Nephrotic Syndrome Study Network

Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Cohort A (biopsy cohort) Who May Qualify: 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 Who May Qualify: - 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) Who May Qualify: - 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 willing to sign a consent form - Unwillingness to comply with study procedures and visit schedule - Institutionalized individuals (e.g., prisoners) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

PROCEDURE

Kidney Biopsy

Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.

Locations (20)

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
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University - St Louis
St Louis, Missouri, United States
Cohen Children's Hospital
New Hyde Park, New York, United States
New York University Medical Center
New York, New York, United States
Bellevue Hospital
New York, New York, United States