Nephrotic Syndrome Study Network

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Trial ID: NCT01209000

Age - N/A-80 Years Gender - All Accepting Healthy Volunteers - No

Purpose

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.

Official Title

Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

Stanford Investigator(s)

Richard Lafayette
Richard Lafayette

Professor of Medicine (Nephrology)

Eligibility


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)

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Intervention(s):

procedure: Kidney Biopsy

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240

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