Prevalence of Renal Disease in Children With Celiac Disease
COELIGAN
2 other identifiers
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 8, 2021
July 1, 2021
1 year
September 9, 2021
October 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
urine sample taken during consultations
Eligibility Criteria
children with Celiac Disease
You may qualify if:
- children with Celiac Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debre Hospital
Paris, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivia Baylet Fernandez, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
September 20, 2021
Study Start
October 1, 2021
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 8, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share