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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal of the patient or legal representatives to participate in the cohort

Trial population

Pediatric idiopathic nephrotic syndrome

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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).

Treatment groups

1,180 Participants
are divided into 1 treatment group
Group A: Inclusion and follow up of pediatric patients1 intervention

Trial outcomes

Primary outcomes

1

Number of cases included in the cohort and description of their characteristics

* 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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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