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NCT Number: NCT04207580

A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.

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.

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Key information

Conditions

Idiopathic Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrosis, Lipoid Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Agen, Agen, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,

Other

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 outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Bahans, PhD

CONTACT

[email protected]

+33 5 55 05 63 58

Vincent Guigonis, MD

CONTACT

[email protected]

+33 5 55 0563 58

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: PIN'SNP

Important dates

Study start: 2020
Primary completion: 2030
Study completion: 2048
First posted: Dec 23, 2019
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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