Actively Recruiting
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
Eligibility Criteria
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)
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
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
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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