The Nephrotic Syndrome Study Network (NEPTUNE)

The Nephrotic Syndrome Study Network (NEPTUNE) is a collaborative investigational infrastructure of 40 North American sites for conducting clinical and translational research in Focal Segmental Glomerulosclerosis (FSGS), Membranous Nephropathy (MN), and Minimal Change Disease (MCD). NEPTUNE provides prospective, un-blinded, standardized evaluation of clinical and molecular outcomes in two cohorts: A) adults and children with incident or prevalent, biopsy-proven FSGS, MN, or MCD, recruited at the time of first biopsy, and B) children with incident Nephrotic Syndrome without a diagnostic kidney biopsy.]]>
Inclusion Criteria:Cohort A: Incident requires 1.5 g/g Urine Protein-to-Creatinine Ratio (UPCR)Prevalent requires prior biopsy-confirmed diagnosis of one of the target diseasesIncident or prevalent requires a kidney biopsy for entryCohort B: Non-biopsy< 19 years oldUPCR > 2.0 and Edema orUrine Albumin (UA) > 2.0 and Serum Albumin < 3.0 orUPCR > 2.0 and Serum Albumin < 3.0 orUA > 2.0 and EdemaNo immunosuppression therapy > 30 days Exclusion Criteria: End stage kidney diseaseSolid organ transplantClinical, serological, or histological evidence of systemic lupus erythematosus (SLE) or antineutrophil cytoplasmic antibodies (ANCA) vasculitisClinical or histological evidence of other renal diseases: nail patella syndrome (NPS), diabetic nephropathy (DN), monoclonal gammopathy (multiple myelomas)Genito-urinary malformations with vesicoureteral reflux or renal dysplasiaLife expectancy < 6 monthsUnwillingness to comply with study procedures and visit scheduleSecondary nephrotic syndrome (SLE, vasculitis, Henoch-Schönlein purpura, Hepatitis B, Hepatitis C, or HIV nephropathy)Institutionalized individuals ]]>
NEPTUNE 1 (Single Cohort): Incident kidney biopsy only, with > 0.5 g/g UPCRNEPTUNE 2 (Two Cohorts): (A) Incident kidney biopsy only, with > 1.5 g/g UPCR, and (B) Non-biopsy, pediatric cohort of newly diagnoses nephrotic syndromeNEPTUNE 3 (Two Cohorts): (A) Incident kidney biopsy with > 1.5 g/g UPCR or prevalent kidney biopsy with prior confirmed diagnosis of FSGS, MCD or MN, and (B) Non-biopsy, pediatric cohort of newly diagnoses nephrotic syndrome]]>