Prevalence of Renal Disease in Children With Celiac Disease (COELIGAN)

To assess the prevalence of renal disease in a pediatric population of patients with celiac disease by looking for the presence of hematuria and/or proteinuria.

Study Overview

• Status: Not yet recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Other: urine sample taken during consultations

Detailed Description

In this study the investigators seek to quantify the prevalence of urine sediment abnormalities in children with celiac disease to assess whether there is value in screening for renal disease in this population. Celiac disease (CD) is frequently accompanied by a variety of extra-digestive manifestations, making it a systemic disease rather than a disease limited to the gastrointestinal tract. CD belongs to the group of autoimmune diseases, a significantly increased prevalence of other autoimmune diseases (AD) has been reported in individuals with CD and their first-degree relatives, and a significantly increased prevalence of CD has been documented in individuals with other AD. The association between CD and other ADs may be explained by a shared pathogenic basis, involving genetic susceptibility as in type 1 diabetes (T1D), similar environmental triggers, increased intestinal permeability, and possibly by undiscovered mechanisms. Many of the extraintestinal manifestations of CD involve the kidney. Urolithiasis and crystal-induced renal disease, nephrogenic ascites, increased risk of end-stage renal disease, and membranoproliferative glomerulonephritis type 1 are associated with CD. However, little is known about the risk of kidney disease in individuals with CD, and it would be interesting to assess the prevalence of urine sediment abnormalities in a pediatric population at diagnosis and during follow-up. No previous studies have examined the risk of renal disease, and there are currently no recommendations for screening for renal involvement in patients with CD.

One of the renal conditions that particularly attracts our attention is IgA nephropathy (NIgA). First, studies suggest a common pathogenic basis between this nephropathy and CD and second, it is one of the most common primary glomerulonephritis in children and adolescents worldwide. NIgA usually progresses to end-stage renal disease (ESRD) within 20 years; the median age of patients starting dialysis ranges from 40 to 50 years. Cohort studies with extensive follow-up show that 10-13% of children eventually reach ESRD within 10 years and 20-30% within 20 years. In more than half of cases, NIgA is asymptomatic (microscopic hematuria) and is diagnosed after an incidental finding of hypertension, subnormal glomerular filtration rate, hematuria, and/or proteinuria in children and adults. Renin-angiotensin system inhibitors have shown effective results in reducing the progression of kidney damage in young NigA patients with moderate proteinuria.

In view of its potential severity, the arguments in favor of its association with CD, its generally asymptomatic clinical presentation, and the usefulness of its early detection, it seems interesting to us to evaluate the prevalence of urinary abnormalities characteristic of NigA in children with celiac disease. The results of this study could have an impact on the prevention of renal disease in patients with celiac disease.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Olivia Baylet Fernandez, MD; Phone Number: +331.40.03.16.29; Email: olivia.bayletfernandez@aphp.fr
• Study Contact Backup: Name: Sabrina Verchere; Phone Number: +331.40.03.47.38; Email: sabrina.verchere@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital
    • Contact: Olivia Baylet Fernandez, MD; Phone Number: +331.40.03.16.29; Email: olivia.bayletfernandez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children with Celiac Disease

Description

Inclusion Criteria:

• children with Celiac Disease

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine sediment abnormalities (proteinuria , creatininuria)	measurement of proteinuria, creatininuria and urine cytology Hematuria is defined by a number of red blood cells in the urine greater than or equal to 10,000 / ml. This will be carried out by counting red blood cells by an automatic device. The search for proteinuria will be carried out on a urination by an automatic device. Proteinuria is considered positive when the urine protein / creatinine ratio is 0.03 g / mmol. In case of positive proteinuria we will measure the microalbuminuria on the same sample.	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Olivia Baylet Fernandez, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: APHP200251; IDRCB: 2020-A00316-33 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No