Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2010-04-30
2029-06-30
Brief Summary
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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.
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Detailed Description
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The prevailing classification of Nephrotic Syndrome categorizes patients into FSGS, MCD, and MN, if in the absence of other underlying causes, glomerular histology shows a specific histological pattern. This classification does not adequately predict the heterogeneous natural history of patients with FSGS, MCD, and MN. Major advances in understanding the pathogenesis of FSGS and MCD have come over the last ten years from the identification of several mutated genes responsible for causing Steroid Resistant Nephrotic Syndrome (SRNS) presenting with FSGS or MCD histopathology in humans and model organisms. These functionally distinct genetic disorders can present with indistinguishable FSGS lesions on histology confirming the presence of heterogeneous pathogenic mechanisms under the current histological diagnoses.
The limited understanding of FSGS, MCD, and MN biology in humans has necessitated a descriptive classification system in which heterogeneous disorders are grouped together. This invariably consigns these heterogeneous patients to the same therapeutic approaches, which use blunt immunosuppressive drugs that lack a clear biological basis, are often not beneficial, and are complicated by significant toxicity. The foregoing shortcomings make a strong case that concerted and innovative investigational strategies combining basic science, translational, and clinical methods should be employed to study FSGS, MCD, and MN. It is for these reasons that the Nephrotic Syndrome Study Network is established to conduct clinical and translational research in patients with FSGS/MCD and MN.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
cNEPTUNE (Cohort B)
Participants \< 19 years of age, with \< 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
80 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The NephCure Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Matthias Kretzler
Professor
Principal Investigators
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Matthias Kretzler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
New York University Veterans Administration
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
University Hospital Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
MetroHealth Hospital at Case Western Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas-Southwestern
Dallas, Texas, United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Providence Medical Research Center
Spokane, Washington, United States
York Central Hospital
Richmond Hill, Ontario, Canada
Scarborough Hospital
Scarborough Village, Ontario, Canada
Credit Valley Hospital
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Villarreal
Role: backup
References
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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.
Solagna 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.
Kang 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.
Hogan 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.
Related Links
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Rare Diseases Clinical Research Networks Homepage
Patient Advocacy group for FSGS/MCD
Patient advocacy group for MN
The NEPTUNE Study Homepage
Other Identifiers
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6801
Identifier Type: -
Identifier Source: org_study_id
NCT01240564
Identifier Type: -
Identifier Source: nct_alias
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