| NCT ID | NCT01209000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Minimal Change Disease (MCD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2010-04 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2010-04 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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% 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 Criteria
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)
Contact & Investigator
Matthias Kretzler, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT01209000 clinical trial?
This trial is open to participants of all sexes, up to 80 Years, studying Minimal Change Disease (MCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01209000 currently recruiting?
Yes, NCT01209000 is actively recruiting participants. Contact the research team at NEPTUNE-Study@umich.edu for enrollment information.
Where is the NCT01209000 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, San Francisco, United States, Torrance, United States and 11 additional locations.
Who is sponsoring the NCT01209000 clinical trial?
NCT01209000 is sponsored by University of Michigan. The principal investigator is Matthias Kretzler, MD at University of Michigan. The trial plans to enroll 1,200 participants.