Status:
COMPLETED
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
Lead Sponsor:
NYU Langone Health
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
9-18 years
Brief Summary
Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS who will benefi...
Eligibility Criteria
Inclusion
- Steroid sensitive NS: complete remission of proteinuria in response to administration of a standard course of corticosteroids
- Difficult-to-manage NS: disease that cannot be controlled without incurring intolerable side effects from currently available immunosuppressive agents, namely corticosteroids, calcineurin inhibitors, mycophenolate mofetil, or rituximab. Patients with biopsy-proven MCD or FSGS will be eligible as long as they have steroid sensitive disease. However, a renal biopsy will not be required for enrollment into the trial.
Exclusion
- Any patient diagnosed with nephrotic syndrome that is not considered steroid sensitive or frequently relapsing
- Pre-existing celiac disease or gastro-intestinal disorder that precludes use of a GFD
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03387176
Start Date
December 1 2017
End Date
June 14 2021
Last Update
June 22 2021
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016