Status:
RECRUITING
Nephrotic Syndrome Study Network
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The NephCure Foundation
Conditions:
Minimal Change Disease (MCD)
Membranous Nephropathy
Eligibility:
All Genders
Up to 80 years
Brief 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...
Detailed Description
Idiopathic Nephrotic Syndrome (NS) is a rare disease syndrome responsible for approximately 12% of all causes of end-stage kidney disease (ESRD) and up to 20% of ESRD in children. Treatment strategies...
Eligibility Criteria
Inclusion
- 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
- Exclusion Criteria (Cohort A\&B):
- Prior solid organ transplant
- 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)
- 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
- Unwillingness or inability to give a comprehensive informed consent
- Unwillingness to comply with study procedures and visit schedule
- Institutionalized individuals (e.g., prisoners)
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01209000
Start Date
April 1 2010
End Date
June 30 2029
Last Update
April 24 2025
Active Locations (44)
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1
University of Southern California-Children's Hospital
Los Angeles, California, United States, 90227
2
Stanford University School of Medicine
Palo Alto, California, United States, 94304
3
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, United States, 94158
4
Lundquist Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, United States, 90502