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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Idiopathic Nephrotic Syndrome Other: Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,

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.

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine


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.

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).





Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood, urine, hair and nails will be collected at the beginning of the NIS (before starting immunosuppressive treatment).


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric idiopathic nephrotic syndrome
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

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): NCT04207580


Contacts
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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

Locations
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France
Limoges Hospital Recruiting
Limoges, France, 87 042
Contact: Vincent GUIGONIS, MD    +33 5 55 05 63 58    vincent.guigonis@unilim.fr   
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Vincent Guigonis, MD University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04207580    
Other Study ID Numbers: 87RI19_0006
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Cohort - Idiopathic nephrotic syndrome - child
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases