Actively Recruiting

Age: 0 - 80Years
All Genders
NCT01209000

Nephrotic Syndrome Study Network

Led by University of Michigan · Updated on 2025-04-24

1200

Participants Needed

44

Research Sites

1004 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nephrotic Syndrome Study Network

Who Can Participate

Age: 0 - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a new clinical diagnosis of FSGS, MCD, or MN, or pediatric patients without prior biopsy but clinically diagnosed
  • Documented urinary protein excretion of at least 1500 mg per 24 hours or equivalent spot protein:creatinine ratio at diagnosis or within 3 months before screening
  • Scheduled for kidney biopsy (for biopsy cohort)
  • Age under 19 years (for non-biopsy pediatric cohort)
  • Initial presentation with less than 30 days of immunosuppressive treatment (for non-biopsy pediatric cohort)
  • Proteinuria/nephrotic syndrome defined by either urine analysis showing 2+ or more and edema, OR urine analysis 2+ or more with serum albumin under 3 g/dL, OR urine protein to creatinine ratio over 2 g/g with serum albumin under 3 g/dL (for non-biopsy pediatric cohort)
Not Eligible

You will not qualify if you...

  • Prior solid organ transplant
  • Clinical diagnosis of glomerulopathy without a diagnostic kidney biopsy
  • Evidence of systemic lupus erythematosus (SLE) by clinical, serological, or histological criteria
  • Presence of other kidney diseases such as Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA nephritis, monoclonal gammopathy (multiple myeloma), or genitourinary malformations with reflux or dysplasia
  • Known systemic disease with life expectancy less than 6 months at enrollment
  • Unable or unwilling to provide informed consent or comply with study procedures
  • Institutionalized individuals such as prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 44 locations

1

University of Southern California-Children's Hospital

Los Angeles, California, United States, 90227

Actively Recruiting

2

Stanford University School of Medicine

Palo Alto, California, United States, 94304

Actively Recruiting

3

University of California San Francisco Benioff Children's Hospitals

San Francisco, California, United States, 94158

Not Yet Recruiting

4

Lundquist Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, United States, 90502

Actively Recruiting

5

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Not Yet Recruiting

6

University of Colorado Anschutz School of Medicine

Aurora, Colorado, United States, 80045

Not Yet Recruiting

7

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

Actively Recruiting

8

Emory University and Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

9

John Stroger Cook County Hospital

Chicago, Illinois, United States, 60680

Actively Recruiting

10

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

11

Johns Hopkins Medical Institute

Baltimore, Maryland, United States, 21287

Actively Recruiting

12

Kidney Disease Section, NIDDK, NIH

Bethesda, Maryland, United States, 20892

Completed

13

CS Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

14

University of Michigan Medical Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

15

Mayo Clinic

Rochester, Minnesota, United States, 55905

Completed

16

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

17

Washington University - St Louis

St Louis, Missouri, United States, 63110

Not Yet Recruiting

18

Cohen Children's Hospital

New Hyde Park, New York, United States, 11040

Actively Recruiting

19

New York University Medical Center

New York, New York, United States, 10010

Actively Recruiting

20

Bellevue Hospital

New York, New York, United States, 10016

Actively Recruiting

21

New York University Veterans Administration

New York, New York, United States, 10016

Actively Recruiting

22

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

23

Montefiore Medical Center

The Bronx, New York, United States, 11040

Actively Recruiting

24

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

25

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States, 28203

Actively Recruiting

26

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States, 27157

Withdrawn

27

University Hospital Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States, 44106

Completed

28

MetroHealth Hospital at Case Western Medical Center

Cleveland, Ohio, United States, 44109

Completed

29

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

30

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

31

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

32

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

33

Temple University

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

34

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

35

University of Texas-Southwestern

Dallas, Texas, United States, 75390

Actively Recruiting

36

Texas Children's Hospital - Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

37

Seattle Children's Hospital

Seattle, Washington, United States, 98145

Actively Recruiting

38

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

39

Providence Medical Research Center

Spokane, Washington, United States, 99204

Actively Recruiting

40

York Central Hospital

Richmond Hill, Ontario, Canada, L4C 4Z3

Completed

41

Scarborough Hospital

Scarborough Village, Ontario, Canada, M1H 3G4

Completed

42

Credit Valley Hospital

Toronto, Ontario, Canada, L5M 2N1

Actively Recruiting

43

Sunnybrook Hospital

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

44

University Health Network

Toronto, Ontario, Canada, M5G2C4

Actively Recruiting

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Research Team

C

Chrysta C. Lienczewski, BS

CONTACT

A

Amanda Williams, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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