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Nephrotic Syndrome Study Network

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, Atlanta, Aurora, Baltimore, Bethesda, Chapel Hill, Charleston, Charlotte, Chicago, Cleveland, Columbus, Dallas, Houston, Kansas City, Los Angeles, Miami, New Hyde Park, New York, Palo Alto, Philadelphia, Rochester, San Francisco, Seattle, Spokane, St Louis, The Bronx, Torrance, and Winston-Salem, United StatesSee the 39 sitesAlso in 1 other country, 5 sites
Trial code
Status
Recruiting
People taking part
1,200 people, planned
Started
Apr 2010
Expected to end
31 Dec 2030
Type of study
Observational, 4 groups
Treatments tested
  • Kidney Biopsy
Record updated
10 November 2026

Who can take part

Age
Up to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who cannot take part

  • Prior solid organ transplant
  • 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
  • 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)
  • Unwillingness or inability to give a comprehensive informed consent
  • Unwillingness to comply with study procedures and visit schedule
  • Institutionalized individuals (e.g., prisoners)

Other criteria

  • 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

Where in United States

Also in 1 other country, 5 sites

  • CS Mott Children's Hospital, University of MichiganAnn Arbor, United StatesContact: Hailey Desmond, MSTaking people
  • University of Michigan Medical CenterAnn Arbor, United StatesContact: Chrysta C. Lienczewski, BS - adultTaking people
  • Emory University and Children's Healthcare of AtlantaAtlanta, United StatesContact: Emily YunTaking people
  • Children's Hospital ColoradoAurora, United StatesContact: Nathan RogersNot yet recruiting
  • University of Colorado Anschutz School of MedicineAurora, United StatesContact: Elizabeth WagnerNot yet recruiting
  • Johns Hopkins Medical InstituteBaltimore, United StatesContact: Sara BoyntonTaking people
  • Kidney Disease Section, NIDDK, NIHBethesda, United StatesContact: Chrysta C. Lienczewski, BSNo longer taking part
  • University of North Carolina at Chapel HillChapel Hill, United StatesContact: Anne FromentTaking people
  • Medical University of South CarolinaCharleston, United StatesContact: David Selewski, MD, MS (principal investigator)Taking people
  • Atrium Health/Levine Children's HospitalCharlotte, United StatesContact: Layla LoTaking people
  • John Stroger Cook County HospitalChicago, United StatesContact: Mathew ItteeraTaking people
  • Cleveland ClinicCleveland, United StatesContact: Stefanie LarsonTaking people
  • MetroHealth Hospital at Case Western Medical CenterCleveland, United StatesContact: Chrysta C. Lienczewski, BSNo longer taking part
  • University Hospital Rainbow Babies & Children's HospitalCleveland, United StatesContact: Chrysta C. Lienczewski, BSNo longer taking part
  • The Ohio State University -Wexner Medical CenterColumbus, United StatesContact: Alexander PriceTaking people
  • University of Texas, SouthwesternDallas, United StatesContact: Elizabeth RoblesTaking people
  • Texas Children's Hospital/ Baylor College of MedicineHouston, United StatesContact: Aisha DeslandesTaking people
  • Children's Mercy HospitalKansas City, United StatesContact: Kelsey MarkusTaking people
  • University of Kansas Medical CenterKansas City, United StatesContact: Catherine CreedTaking people
  • University of Southern California-Children's HospitalLos Angeles, United StatesContact: Sharon Tang, BSNTaking people
  • University of Miami Miller School of MedicineMiami, United StatesContact: Carlos BidotTaking people
  • Cohen Children's HospitalNew Hyde Park, United StatesContact: Suzanne Vento, BSNTaking people
  • Bellevue HospitalNew York, United StatesContact: Frank Modersitzki, MPHTaking people
  • Columbia University Medical CenterNew York, United StatesContact: Anup PradhanTaking people
  • New York University Medical CenterNew York, United StatesContact: Frank Modersitzki, MPH - adultTaking people
  • New York University Veterans AdministrationNew York, United StatesContact: Frank Modersitzki, MPHTaking people
  • Stanford University, School of MedicinePalo Alto, United StatesContact: Kshama Mehta, PhDTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Alilya EdwardsTaking people
  • Temple UniversityPhiladelphia, United StatesContact: Zoe Pfeffer, BSTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Krishna Kallem, MD - adult, MSTaking people
  • Mayo ClinicRochester, United StatesContact: Chrysta C. Lienczewski, BSNo longer taking part
  • University of California San Francisco Benioff Children's HospitalsSan Francisco, United StatesContact: Daniel SchraderNot yet recruiting
  • Seattle Children's HospitalSeattle, United StatesContact: Emily PaoTaking people
  • University of WashingtonSeattle, United StatesContact: Linda Manahan, BSNTaking people
  • Providence Medical Research CenterSpokane, United StatesContact: Ann Cooper, CCRCTaking people
  • Washington University St. LouisSt Louis, United StatesContact: Leslie WaltherNot yet recruiting
  • Montefiore Medical CenterThe Bronx, United StatesContact: Patti Flynn, RNTaking people
  • Lundquist Biomedical Research Institute at Harbor UCLA Medical CenterTorrance, United StatesContact: Janine LaPageTaking people
  • Wake Forest School of MedicineWinston-Salem, United StatesContact: Chrysta C. Lienczewski, BSNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • 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.

    Treatment: Kidney 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.

    Treatment: Kidney 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.

    Treatment: Kidney Biopsy

  • cNEPTUNE (Cohort B)

    Participants \< 19 years of age, with \< 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network
Record updated
10 November 2026
Nephrotic Syndrome Study Network (NCT01209000) – Frontlight Research