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Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker

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ClinicalTrials.gov Identifier: NCT03387176
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Nephrotic Syndrome Other: Implementation of a gluten-free diet

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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
Other: Implementation of a gluten-free diet
Patients will be placed on gluten free diet for 9-12 months.
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
Other: Implementation of a gluten-free diet
Patients will be placed on gluten free diet for 9-12 months.


Outcome Measures

Primary Outcome Measures :
  1. Change in disease activity measured by relapse rate [ Time Frame: 12 Months ]
    Response is defined as a ≥50%decrease in relapse rate

  2. Change in disease activity measured by change in dosage of corticosteroids and immunosuppressive medications [ Time Frame: 12 Months ]
    reduction by ≥1 drug in exposure to immunosuppressive medications in response to the GFD


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children age 9 months to 18 years of age with steroid sensitive Nephrotic Syndrome
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387176


Contacts
Contact: Suzanne Vento 646 501 2665 Suzanne.Vento@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Suzanne Vento, MD    646-501-2665    Suzanne.Vento@nyumc.org   
Principal Investigator: Howard Trachtman, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Howard Trachtman, MD New York University School of Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03387176     History of Changes
Other Study ID Numbers: 17-01307
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases