Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 12/29/2018 |
| Start Date: | December 1, 2017 |
| End Date: | March 31, 2019 |
| Contact: | Suzanne Vento |
| Email: | Suzanne.Vento@nyumc.org |
| Phone: | 646 501 2665 |
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 benefit from initiation of a GFD (gluten free diet). This pilot study will determine
whether high plasma zonulin levels can be used as a screening tool to identify patients with
NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will
provide important information about the feasibility of testing the efficacy of a GFD for this
condition and assist in the design and sample size calculation for a definitive trial to test
the beneficial effect of this dietary intervention. Although NS is a rare condition in
childhood, it is a chronic disease that can lead to short- and long-term disability
especially in those with difficult-to-manage disease. There is an urgent need to develop safe
and effective new therapies in this subgroup. This project may indicate the utility of a
common dietary modification, a GFD, to treat these patients. The growing medical use of and
greater access to gluten-free food items underscore the feasibility and timeliness of this
approach.
children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS
who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine
whether high plasma zonulin levels can be used as a screening tool to identify patients with
NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will
provide important information about the feasibility of testing the efficacy of a GFD for this
condition and assist in the design and sample size calculation for a definitive trial to test
the beneficial effect of this dietary intervention. Although NS is a rare condition in
childhood, it is a chronic disease that can lead to short- and long-term disability
especially in those with difficult-to-manage disease. There is an urgent need to develop safe
and effective new therapies in this subgroup. This project may indicate the utility of a
common dietary modification, a GFD, to treat these patients. The growing medical use of and
greater access to gluten-free food items underscore the feasibility and timeliness of this
approach.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Howard Trachtman, MD
Phone: 646-501-2665
New York University School of Medicine NYU School of Medicine has a proud history that...
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