Determinants of medication adherence in childhood nephrotic syndrome and associations of adherence with clinical outcomes.
Chia-Shi Wang, Jonathan P Troost, Yujie Wang...
https://pubmed.ncbi.nlm.nih.gov/34796395Actively Recruiting
Age: 0 - 80Years
All Genders
ID01209000
Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network
Led by University of Michigan ยท Updated on 2025-04-24
1200
Participants Needed
44
Research Sites
N/A
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
Nephrotic Syndrome (NS), including Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS), and Membranous Nephropathy (MN), causes a significant financial and health burden, contributing to about 12% of end-stage renal disease (ESRD) cases. Current treatments are often not very effective and can have serious side effects. This study aims to better understand these rare diseases by collecting long-term observational data and biological samples to improve knowledge and care strategies. Participants are grouped based on their biopsy-confirmed diagnosis of FSGS, MCD, or MN, or into an additional group if they do not have these conditions. Some pediatric participants under 19 years old with limited prior immunosuppressive treatment and not scheduled for biopsy can also join. Study involvement includes consenting for an additional kidney biopsy core during clinically indicated procedures for tissue analysis. During the study, researchers will monitor changes in urinary protein levels and kidney function over 60 months. Various health outcomes such as quality of life, infections, hospitalizations, kidney injury, and other medical events will also be tracked. Participants are followed regularly with data and specimen collection to support research into better understanding and managing these kidney diseases.
CONDITIONS
Brief Title
Nephrotic Syndrome Study Network
Who Can Participate
Age: 0 - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with an early clinical diagnosis of FSGS, MCD, or Membranous Nephropathy
- Documented urinary protein excretion of 1500 mg or more per 24 hours, or equivalent protein:creatinine ratio
- Scheduled for a clinically indicated kidney biopsy (for biopsy cohort)
- Children under 19 years old with less than 30 days of immunosuppression therapy
- Proteinuria or nephrotic syndrome confirmed by urine analysis and serum albumin criteria (for pediatric non-biopsy cohort)
You will not qualify if you...
- Prior solid organ transplant
- Diagnosis of glomerulopathy without diagnostic kidney biopsy
- Clinical, serological, or histological evidence of systemic lupus erythematosus (SLE)
- Presence of other kidney diseases such as Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA nephritis, monoclonal gammopathy, or genitourinary malformations
- Known systemic disease with life expectancy under 6 months
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to follow study procedures and visit schedule
- Institutionalized individuals, such as prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Day of biopsy
Participants scheduled for a clinically indicated kidney biopsy undergo the biopsy procedure, which includes collection of an additional renal core for research purposes.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants are followed with regular assessments to monitor urinary protein excretion, renal function, and other health outcomes over time.
Visits occur periodically over 60 months
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
A
Amanda Williams, BS
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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