- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207580
A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood. (PIN'SNP)
Pediatric idiopathic nephrotic syndrome (INS) is a rare disease for which the optimal therapeutic strategy has not yet been defined. A network of clinicians treating complicated forms of this disease (grouped within the Société de Néphrologie Pédiatrique, SNP) exists, but to date there is no prospective cohort following up these patients that would facilitate the development of cohort-nested trials. This absence of structured follow up makes it difficult to set up prospective studies.
The main objective is to create a prospective cohort of pediatric INS patients to collect cases treated in SNP centers, to study their epidemiological characteristics, and to provide a basis for comparison for future cohort-nested trials.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, data from patients with INS will be recorded prospectively, regularly and systematically. The cohort will be composed of patients followed by pediatric nephrologists affiliated with the SNP. Metropolitan France, Reunion Island and Mayotte are the geographical areas concerned. It is planned to integrate other French overseas departments and territories, in particular the West Indies.
This is therefore a prospective, multicenter, cohort follow-up study. The data will be centralized via a secure website dedicated to the study.
Data will be obtained from:
- Medical record data (hospitalization/consultations) as part of routine clinical follow-up for patients with active disease. This information will be medically validated and integrated into the database with the help of clinical research staff.
- A telephone interview for annual follow-ups for patients whose absence of active disease no longer requires a systematic medical visit. This structured interview will be administered by telephone by the study's clinical research staff.
- Self-administered or hetero-administered quality of life questionnaires (PEDS-QL), self-administered or hetero-administered treatment compliance questionnaires (Morisky's Score), and questionnaires on the aesthetic impact of treatments (Ferriman's Score). These questionnaires will be centralized and reported to the database by the study's clinical research staff.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vincent Guigonis, MD
- Phone Number: +33 5 55 0563 58
- Email: vincent.guigonis@unilim.fr
Study Contact Backup
- Name: Claire Bahans, PhD
- Phone Number: +33 5 55 05 63 58
- Email: claire.bahans@chu-limoges.fr
Study Locations
-
-
-
Limoges, France, 87 042
- Recruiting
- Limoges hospital
-
Contact:
- Vincent GUIGONIS, MD
- Phone Number: +33 5 55 05 63 58
- Email: vincent.guigonis@unilim.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient under 18 years of age
- With idiopathic nephrotic syndrome (according to SPN criteria) beginning after January 1, 2018
- Child seen at least once in consultation or hospitalization by a pediatrician member of the Society of Pediatric Nephrology
- Residing in France
- Consent signed by parents and patient's agreement to participate (if of age)
- Affiliated to a social security system.
Exclusion Criteria:
- Refusal of the patient or legal representatives to participate in the cohort
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Inclusion and follow up of pediatric patients
Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome, from the beginning of the disease to 18 years old or transfer of the follow-up to a nephrology unit for adults. 130 new patients are expected to be included on an annual basis. |
The study consists in collecting clinical, biological, psychological and social data of INS pediatric patients. A bio collection is also created: blood, urine, hair and nails will be collected at the beginning of the INS (before starting immunosuppressive treatment). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of cases included in the cohort and description of their characteristics
Time Frame: 2 years
|
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent GUIGONIS, MD, University Hospital, Limoges
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI19_0006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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