Nephrotic Syndrome Study Network
NEPTUNE
2 other identifiers
observational
1,200
2 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
April 24, 2025
April 1, 2025
19.3 years
July 29, 2010
April 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event rate of change in urinary protein excretion and renal function.
Defined as remission, partial remission and non-remission
60 months
Rate of change in renal function.
Defined as: 1. 25 mls/min/1.73m2 reduction in follow-up estimated GFR (using the 4-variable MDRD equation for ages ≥18 years and modified Schwartz for ages \<18 years) compared to baseline estimated GFR 2. 50% decline in follow-up estimated GFR compared to baseline measurement 3. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or preemptive kidney transplantation.
60 months
Secondary Outcomes (9)
Quality of Life:
60 months
Malignancies
60 months
Infections, Serious and Systemic
60 months
Thromboembolic Events
60 months
Hospitalization
60 months
- +4 more secondary outcomes
Study Arms (4)
FSGS/MCD Cohort (Cohort A)
Focal Segmental Glomerulosclerosis/Minimal Change Disease (FSGS/MCD) Cohort Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for FSGS or MCD. Eligible participants must be scheduled for a clinically indicated renal biopsy.
MN Cohort (Cohort A)
Membranous Nephropathy (MN) Cohort Participants enrolled in NEPTUNE with a biopsy proven histological diagnosis for MN. Eligible participants must be scheduled for a clinically indicated renal biopsy.
Other glomerulopathies cohort
Participants enrolled in NEPTUNE and determined to not have FSGS/MCD or MN will be followed in a third group. Eligible participants must be scheduled for a clinically indicated renal biopsy.
cNEPTUNE (Cohort B)
Participants \< 19 years of age, with \< 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.
Interventions
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.
Eligibility Criteria
Patients with signs and symptoms of kidney disease consistent with FSGS, MCD, MN or proteinuric renal disease or pediatric participants not previously biopsied, who present for patient care at participating clinical centers will be eligible for Cohort A (biopsy cohort) study population targeted for enrollment into the NEPTUNE study. To establish a cohort of pediatric participants with incident nephrotic syndrome, Cohort B, a non-biopsy cohort has been initiated for Protocol V4.0. This population, \<19 years of age, presenting for nephrotic syndrome and less than 30 days of immunosuppression therapy exposure, will also be targeted for enrollment into the cNEPTUNE study. Potential participants willing to receive their initial care and subsequent follow-up study visits at one of these sites are welcome to participate.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
University of Southern California-Children's Hospital
Los Angeles, California, 90227, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, 94158, United States
Lundquist Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Emory University and Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
John Stroger Cook County Hospital
Chicago, Illinois, 60680, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287, United States
Kidney Disease Section, NIDDK, NIH
Bethesda, Maryland, 20892, United States
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University - St Louis
St Louis, Missouri, 63110, United States
Cohen Children's Hospital
New Hyde Park, New York, 11040, United States
New York University Medical Center
New York, New York, 10010, United States
Bellevue Hospital
New York, New York, 10016, United States
New York University Veterans Administration
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 11040, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
University Hospital Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
MetroHealth Hospital at Case Western Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas-Southwestern
Dallas, Texas, 75390, United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98145, United States
University of Washington
Seattle, Washington, 98195, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
York Central Hospital
Richmond Hill, Ontario, L4C 4Z3, Canada
Scarborough Hospital
Scarborough Village, Ontario, M1H 3G4, Canada
Credit Valley Hospital
Toronto, Ontario, L5M 2N1, Canada
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G2C4, Canada
Related Publications (4)
Wang CS, Troost JP, Wang Y, Greenbaum LA, Gibson K, Trachtman H, Srivastava T, Reidy K, Kaskel F, Sethna CB, Meyers K, Dell KM, Tran CL, Hingorani S, Lemley KV, Lin JJ, Gipson DS. Determinants of medication adherence in childhood nephrotic syndrome and associations of adherence with clinical outcomes. Pediatr Nephrol. 2022 Jul;37(7):1585-1595. doi: 10.1007/s00467-021-05176-8. Epub 2021 Nov 18.
PMID: 34796395DERIVEDSolagna F, Tezze C, Lindenmeyer MT, Lu S, Wu G, Liu S, Zhao Y, Mitchell R, Meyer C, Omairi S, Kilic T, Paolini A, Ritvos O, Pasternack A, Matsakas A, Kylies D, Wiesch JSZ, Turner JE, Wanner N, Nair V, Eichinger F, Menon R, Martin IV, Klinkhammer BM, Hoxha E, Cohen CD, Tharaux PL, Boor P, Ostendorf T, Kretzler M, Sandri M, Kretz O, Puelles VG, Patel K, Huber TB. Pro-cachectic factors link experimental and human chronic kidney disease to skeletal muscle wasting programs. J Clin Invest. 2021 Jun 1;131(11):e135821. doi: 10.1172/JCI135821.
PMID: 34060483DERIVEDKang H, Kim DR, Jung YH, Baek CW, Park YH, In Oh J, Kim WJ, Choi GJ. Pre-warming the Streamlined Liner of the Pharynx Airway (SLIPA) improves fitting to the laryngeal structure: a randomized, double-blind study. BMC Anesthesiol. 2015 Nov 20;15:167. doi: 10.1186/s12871-015-0151-4.
PMID: 26589142DERIVEDHogan MC, Lieske JC, Lienczewski CC, Nesbitt LL, Wickman LT, Heyer CM, Harris PC, Ward CJ, Sundsbak JL, Manganelli L, Ju W, Kopp JB, Nelson PJ, Adler SG, Reich HN, Holzmann LB, Kretzler M, Bitzer M. Strategy and rationale for urine collection protocols employed in the NEPTUNE study. BMC Nephrol. 2015 Nov 17;16:190. doi: 10.1186/s12882-015-0185-3.
PMID: 26577187DERIVED
Related Links
Biospecimen
Renal tissue core (from clinically indicated kidney biopsy procedure) Blood products Urine products DNA/RNA specimens (declining consent does not forego participant eligibility)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias Kretzler, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 29, 2010
First Posted
September 24, 2010
Study Start
April 1, 2010
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
April 24, 2025
Record last verified: 2025-04