Not a traditional drug phase: Kidney Biopsy for Minimal Change Disease (MCD)
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.
Official registry: https://clinicaltrials.gov/study/NCT01209000 · University of Michigan · enrollment listed as 1,200
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 1,200 people at 44 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network
Interventions: Kidney Biopsy
Primary outcome (registry wording): Event rate of change in urinary protein excretion and renal function.
Who it is for (from inclusion criteria)
- Ages any to 80 Years
- Cohort A (biopsy cohort)
- 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 who can join:
- 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) who can join:
- Age \<19 years of age
- Initial presentation with \<30 days immunosuppression therapy
Who the registry excludes
- Prior solid organ transplant
- A clinical diagnosis of glomerulopathy without diagnostic renal biopsy
- 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 to comply with study procedures and visit schedule
- Institutionalized individuals (e.g., prisoners)
Public study contact (from the registry)
Chrysta C. Lienczewski, BS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
44 listed- University of Southern California-Children's Hospital — Los Angeles, California (recruiting)
- Stanford University School of Medicine — Palo Alto, California (recruiting)
- University of California San Francisco Benioff Children's Hospitals — San Francisco, California (not_yet_recruiting)
- Lundquist Biomedical Research Institute at Harbor UCLA Medical Center — Torrance, California (recruiting)
- Children's Hospital Colorado — Aurora, Colorado (not_yet_recruiting)
- University of Colorado Anschutz School of Medicine — Aurora, Colorado (not_yet_recruiting)
- University of Miami Miller School of Medicine — Miami, Florida (recruiting)
- Emory University and Children's Healthcare of Atlanta — Atlanta, Georgia (recruiting)
- John Stroger Cook County Hospital — Chicago, Illinois (recruiting)
- University of Kansas Medical Center — Kansas City, Kansas (recruiting)
- Johns Hopkins Medical Institute — Baltimore, Maryland (recruiting)
- Kidney Disease Section, NIDDK, NIH — Bethesda, Maryland (completed)
+ 5 sites outside the US on the same record
FAQ about this NCT record
Is NCT01209000 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT01209000?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT01209000?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary