Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

• 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

Locations
United States
California
University of Southern California-Children's Hospital
Recruiting
Los Angeles
Stanford University School of Medicine
Recruiting
Palo Alto
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Recruiting
Torrance
Florida
University of Miami Miller School of Medicine
Recruiting
Miami
Georgia
Emory University and Children's Healthcare of Atlanta
Recruiting
Atlanta
Illinois
John Stroger Cook County Hospital
Recruiting
Chicago
Maryland
Johns Hopkins Medical Institute
Recruiting
Baltimore
Kidney Disease Section, NIDDK, NIH
Recruiting
Bethesda
Michigan
CS Mott Children's Hospital, University of Michigan
Recruiting
Ann Arbor
University of Michigan Medical Center
Recruiting
Ann Arbor
Minnesota
Mayo Clinic
Recruiting
Rochester
Missouri
Children's Mercy Hospital
Recruiting
Kansas City
North Carolina
University of North Carolina at Chapel Hill
Recruiting
Chapel Hill
Wake Forest School of Medicine
Recruiting
Winston-salem
New York
Montefiore Medical Center
Recruiting
Bronx
Cohen Children's Hospital
Recruiting
New Hyde Park
Bellevue Hospital
Recruiting
New York
Columbia University Medical Center
Recruiting
New York
New York University Medical Center
Recruiting
New York
New York University Veterans Administration
Recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
MetroHealth Hospital at Case Western Medical Center
Recruiting
Cleveland
University Hospital Rainbow Babies & Children's Hospital
Recruiting
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Temple University
Recruiting
Philadelphia
University of Pennsylvania
Recruiting
Philadelphia
Texas
University of Texas-Southwestern
Recruiting
Dallas
Washington
Seattle Children's Hospital
Recruiting
Seattle
University of Washington
Recruiting
Seattle
Providence Medical Research Center
Recruiting
Spokane
Other Locations
Canada
York Central Hospital
Recruiting
Richmond Hill
Scarborough Hospital
Recruiting
Scarborough
Credit Valley Hospital
Recruiting
Toronto
Sunnybrook Hospital
Recruiting
Toronto
University Health Network
Recruiting
Toronto
Contact Information
Primary
Chrysta C. Lienczewski, BS
NEPTUNE-Study@umich.edu
734-615-5021
Backup
Amanda Williams, BS
NEPTUNE-Study@umich.edu
734-615-5017
Time Frame
Start Date: April 2010
Estimated Completion Date: June 30, 2024
Participants
Target number of participants: 1200
Treatments
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.
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.
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.
cNEPTUNE (Cohort B)
Participants < 19 years of age, with < 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.
Sponsors
Collaborators: The NephCure Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Michigan

This content was sourced from clinicaltrials.gov

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