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A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood. (PIN'SNP)

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ClinicalTrials.gov Identifier: NCT04207580
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Tracking Information
First Submitted Date December 17, 2019
First Posted Date December 23, 2019
Last Update Posted Date April 8, 2020
Actual Study Start Date March 13, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2019)
Number of cases included in the cohort and description of their characteristics [ Time Frame: 2 years ]
  • Number of followed cases, gender, and age
  • Geographical localization of followed cases
  • Progressive disease pattern (relapses, corticosteroid dependence, other treatments used)
  • Serious side effects related to treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.
Official Title A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.
Brief Summary

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.

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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, hair and nails will be collected at the beginning of the NIS (before starting immunosuppressive treatment).
Sampling Method Non-Probability Sample
Study Population Pediatric idiopathic nephrotic syndrome
Condition Idiopathic Nephrotic Syndrome
Intervention Other: Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,

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).

Study Groups/Cohorts 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.

Intervention: Other: Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 20, 2019)
260
Original Estimated Enrollment
 (submitted: December 17, 2019)
236
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vincent Guigonis, MD +33 5 55 0563 58 vincent.guigonis@unilim.fr
Contact: Claire Bahans, PhD +33 5 55 05 63 58 claire.bahans@chu-limoges.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04207580
Other Study ID Numbers 87RI19_0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Limoges
Study Sponsor University Hospital, Limoges
Collaborators Not Provided
Investigators
Principal Investigator: Vincent Guigonis, MD University Hospital, Limoges
PRS Account University Hospital, Limoges
Verification Date October 2019