The Nephrotic Syndrome Study Network (NEPTUNE) is a collaborative investigational infrastructure of 26 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: 1) adults and children with incident, biopsy-proven FSGS, MCD, or MN, recruited at the time of first biopsy, and 2) children with incident NS without a diagnostic kidney biopsy.
Study participants provide a biopsy core at enrollment, plus biosamples (i.e., blood, urine) and clinical data at 4-6 month intervals for a minimum 36 months of follow-up. Data resources further encompass standardized digital histopathology scoring, morphometry, cytokine and chemokine panel in blood and urine, renal biopsy gene expression profiles and whole genome sequencing.
Data and samples are made available to interested researchers through the Pilot and Ancillary Studies Program. Over 100 studies utilizing NEPTUNE resources have been approved. Visit the Ancillary Studies page to learn how to take part in NEPTUNE ancillary studies.
NEPTUNE is a part of the National Institutes of Health RDCRN, supported by the Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Sciences (NCATS), and the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK). The University of Michigan, NephCure Kidney International and the Halpin Foundation provide additional funding and/or programmatic support.
NEPTUNE aims to:
- Deploy a collaborative investigational infrastructure to conduct clinical and translational research in Nephrotic Syndrome (NS)
- Target recruitment into, and maintain follow-up of, the NEPTUNE cohorts comprised of pediatric and adult patients enrolled at the time of first biopsy (Biopsy Cohort) and pediatric patients without biopsy (“cNEPTUNE”)
- Facilitate pilot and ancillary studies that utilize NEPTUNE observational clinical data, biosamples, derived datasets, and/or infrastructure
- Support unique training opportunities for junior faculty preparing for careers in clinical and translational research in glomerular disease
- Collaborate with the RDCRN Data Management Coordinating Center and NKI for outreach to the public, physicians, and scientists
The Nephrotic Syndrome Study Network (NEPTUNE) aims to define Nephrotic Syndrome (NS) in functional terms to identify novel molecular predictors and targeted therapies. The network provides prospective, un-blinded, standardized evaluation of clinical and molecular outcomes in two cohorts: Biopsy Cohort, and the Pediatric Non-Biopsy Cohort (“cNEPTUNE”).
More specifically, the two parallel cohorts of study participants are:
- Adults and children with FSGS, MCD, or MN recruited at the time of first biopsy; and
- Children with NS recruited at the time of first presentation before diagnostic kidney biopsy.
The first cohort began with the initiation of NEPTUNE in 2010; the latter cohort was added with the second funding cycle of NEPTUNE. With the addition of second cohort to NEPTUNE, we have a unique opportunity to study patients from the onset of disease, allowing not just the collection of data, but valuable biosamples that have not been affected by time or medications.
Study participants for both cohorts provide biosamples and clinical data at 4-6 month intervals for a minimum 36 months of follow-up. Study Participants in the non-biopsy cohort additionally receive daily text messages for the first 90 days that they are in the study, and then weekly text messages for the first year. Participants are asked about proteinuria, edema, potential triggers, as well as time missed from school or work due to NS to capture the dynamic nature of the disease process.
NEPTUNE collects from participants:
- Biosamples (urine, blood, biopsy tissue)
- Wide range of demographic and clinical data:
• Socio-Economic Status
• Birth History
• Social History
• Family History
• Pre-kidney/Kidney Disease History
• Medication History
• Clinical Symptoms
• Physical Exam
- Histopathology scoring
- Cytokine and chemokine panel in blood and urine
- Renal biopsy and gene expression profiles
- Whole Genome Sequencing (low depth)
- Exome Chip Genotyping
- High depth targeted sequencing across 21 steroid resistance NS genes
- APOL1 Genotyping (non-Asian, non-European)
Explore the NEPTUNE databases through tranSMART! Contact NEPTUNE-STUDY@umich.edu
NEPTUNE tranSMART is a web-based platform that provides available clinical, biospecimen, and biomarker data in an organized ontology. This allows Investigators to:
- Explore patient population characteristics based on clinical and molecular data
- Generate hypotheses
- Develop ancillary study concepts