- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387176
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
June 21, 2021 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children age 9 months to 18 years of age with steroid sensitive Nephrotic Syndrome
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
zonulin ≤17.5 ng/ml
Pediatric patients with difficult-to-manage nephrotic syndrome will be stratified based on the plasma zonulin concentration into two groups
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Patients will be placed on gluten free diet for 9-12 months.
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zonulin >17.5 ng/ml
Pediatric patients with difficult-to-manage nephrotic syndrome will be stratified based on the plasma zonulin concentration into two groups
|
Patients will be placed on gluten free diet for 9-12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in disease activity measured by relapse rate
Time Frame: 12 Months
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Response is defined as a ≥50%decrease in relapse rate
|
12 Months
|
Change in disease activity measured by change in dosage of corticosteroids and immunosuppressive medications
Time Frame: 12 Months
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reduction by ≥1 drug in exposure to immunosuppressive medications in response to the GFD
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12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Howard Trachtman, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
June 14, 2021
Study Completion (Actual)
June 14, 2021
Study Registration Dates
First Submitted
December 21, 2017
First Submitted That Met QC Criteria
December 21, 2017
First Posted (Actual)
December 29, 2017
Study Record Updates
Last Update Posted (Actual)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-01307
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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