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Nephrotic Syndrome Study Network
NCT01209000 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Kidney Biopsy
Study Locations (20)
California
- University of Southern California-Children's Hospital — Los Angeles
- Stanford University School of Medicine — Palo Alto
- University of California San Francisco Benioff Children's Hospitals — San Francisco
- Lundquist Biomedical Research Institute at Harbor UCLA Medical Center — Torrance
New York
- Cohen Children's Hospital — New Hyde Park
- New York University Medical Center — New York
- Bellevue Hospital — New York
Colorado
- Children's Hospital Colorado — Aurora
- University of Colorado Anschutz School of Medicine — Aurora
Maryland
- Johns Hopkins Medical Institute — Baltimore
- Kidney Disease Section, NIDDK, NIH — Bethesda
Michigan
- CS Mott Children's Hospital, University of Michigan — Ann Arbor
- University of Michigan Medical Center — Ann Arbor
Missouri
- Children's Mercy Hospital — Kansas City
- Washington University - St Louis — St Louis
Florida
- University of Miami Miller School of Medicine — Miami
Georgia
- Emory University and Children's Healthcare of Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2010-04 |
| Est. Completion | 2029-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01209000
The ClinicalTrials.gov registry entry for NCT01209000 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Membranous Nephropathy appearing as the primary indexed condition, and to 1 intervention — of which Kidney Biopsy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01209000 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01209000 about?
NCT01209000 is a clinical study titled "Nephrotic Syndrome Study Network". 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 ...
What is the current status of trial NCT01209000?
This trial is currently recruiting. The enrollment target is 1,200 participants. The study started on 2010-04. Estimated completion is 2029-06-30.
What conditions does trial NCT01209000 study?
This clinical trial studies the following conditions: Membranous Nephropathy, Glomerulosclerosis, Focal Segmental, Minimal Change Disease (MCD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01209000?
The interventions under investigation include: Kidney Biopsy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01209000?
This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01209000 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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