Nephrotic Syndrome Study Network

Conditions

• Glomerulosclerosis, Focal Segmental
• Membranous Nephropathy
• Minimal Change Disease (MCD)

Eligibility Criteria

Sex

ALL

Age

N/A - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Kidney Biopsy — PROCEDURE
  Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.

Study Details

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.

Key Dates

Start date

Apr 30, 2010

Status verified

Jun 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

1,200 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: cNEPTUNE (Cohort B)
  Participants \< 19 years of age, with \< 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.

Primary Outcome Measure

Event rate of change in urinary protein excretion and renal function. [ Time Frame: 60 months ]

Central Contacts

• Chrysta C. Lienczewski, BS
  734-615-5021
  [email protected]
• Amanda Williams, BS
  734-615-5017
  [email protected]

Locations (39)

Find similar trials in Los Angeles, CA

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