NCT04207580

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,180

participants targeted

Target at P75+ for all trials

Timeline
264mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
2 countries

48 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2020Jan 2048

First Submitted

Initial submission to the registry

December 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
18 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2048

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9.8 years

First QC Date

December 17, 2019

Last Update Submit

March 11, 2026

Conditions

Keywords

Cohort - Idiopathic nephrotic syndrome - child

Outcome Measures

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

    2 years

Study Arms (1)

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,

Interventions

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).

Inclusion and follow up of pediatric patients

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric idiopathic nephrotic syndrome

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

CH d'Agen

Agen, 47000, France

RECRUITING

CHU d'Amiens

Amiens, 80000, France

RECRUITING

CHU d'Auxerre

Auxerre, 89000, France

RECRUITING

CH de la côte basque

Bayonne, 64100, France

RECRUITING

CHU de Besançon

Besançon, 25000, France

RECRUITING

CHU de Boredeaux

Bordeaux, 33000, France

RECRUITING

CHU de Brest

Brest, 29609, France

RECRUITING

HCL Lyon

Bron, 69500, France

RECRUITING

CH de Chambéry

Chambéry, 73011, France

RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Dijon

Dijon, 21079, France

RECRUITING

CH du Val d'Ariège

Foix, 09000, France

RECRUITING

CH de la Rochelle

La Rochelle, 17019, France

RECRUITING

CHU de Grenoble

La Tronche, 38700, France

RECRUITING

CH de Versaille

Le Chesnay, 78150, France

RECRUITING

CHU de Lille - Hôpital Jeanne de Flandre

Lille, 59037, France

RECRUITING

Limoges Hospital

Limoges, 87 042, France

RECRUITING

CHU de Marseille - Timone enfants

Marseille, 13385, France

RECRUITING

CH de Macon

Mâcon, 71018, France

RECRUITING

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

RECRUITING

CHU de Nancy

Nancy, 54500, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nice - Hopital Larchet

Nice, 06200, France

RECRUITING

CHU de Nimes

Nîmes, 30900, France

RECRUITING

AP-HP Trousseau

Paris, 75012, France

RECRUITING

AP-HP Robert Debré

Paris, 75019, France

RECRUITING

AP-HP Necker

Paris, 75743, France

RECRUITING

CH de Pau

Pau, 64000, France

RECRUITING

CH de Perpignan

Perpignan, 66000, France

RECRUITING

CH de Périgueux

Périgueux, 24000, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

CH d'Annecy

Pringy, 74374, France

RECRUITING

CHU de Reims

Reims, 57092, France

RECRUITING

CHU de Rennes

Rennes, 35203, France

RECRUITING

CH de Roanne

Roanne, 42300, France

NOT YET RECRUITING

CH de Roubaix

Roubaix, 59100, France

RECRUITING

CHU de Rouen

Rouen, 76031, France

RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

RECRUITING

CH de Sallanches

Sallanches, 74700, France

TERMINATED

CHRU de Strasbourg

Strasbourg, 67200, France

RECRUITING

CH de Toulon

Toulon, 83056, France

RECRUITING

CHU de Toulouse

Toulouse, 31300, France

RECRUITING

CHU de Tours

Tours, 37000, France

RECRUITING

CH de Vannes

Vannes, 56000, France

NOT YET RECRUITING

CH de Villefranche

Villefranche-sur-Saône, 69655, France

RECRUITING

CH de Voiron

Voiron, 38500, France

RECRUITING

CHU de La Réunion - Félix Guyon

Saint-Denis, 97400, Reunion

RECRUITING

CHU de la Réunion

Saint-Pierre, 97448, Reunion

RECRUITING

Related Publications (1)

  • Bahans C, Boyer O, Dunand O, Parmentier C, Ranchin B, Roussey G, Samaille C, Tellier S, Vrillon I, Preka E, Meriguet T, Dubrasquet A, Ichay L, Clave S, Bernardor J, Merieau E, Dossier C, Guigonis V. A "Trial within a Cohort" platform for pediatric clinical trials on idiopathic nephrotic syndrome: scope, objectives, and design of the retrospective-prospective cohort PIN'SNP. Pediatr Nephrol. 2025 Jul;40(7):2225-2238. doi: 10.1007/s00467-025-06676-7. Epub 2025 Mar 3.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, hair and nails will be collected at the beginning of the NIS (before starting immunosuppressive treatment).

MeSH Terms

Conditions

Nephrosis, Lipoid

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Vincent Guigonis, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 23, 2019

Study Start

March 13, 2020

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2048

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations