NCT01386957

Brief Summary

Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in childhood. Currently, all children with INS are treated at onset with steroids. The optimal duration and dosage of steroid therapy is debated. For each patient, the challenge is to minimise potential side effects of steroids, while achieving a good clinical response. The aim of our study is to assess the benefits and potential adverse effects of a prolonged initial corticosteroid regimen, for the treatment of the initial episode. The results will be compared with data obtained retrospectively. In addition genetic studies will be undertaken with the aim of evaluating pharmacodynamics of steroid treatment with the ultimate goal to individualise treatment in single patients.

  1. 1.Study group: children aged 6 months - 18 years, diagnosed with an initial episode of idiopathic nephrotic syndrome
  2. 2.Control group: data of children with a onset INS between January 2007 and December 2009 from the same area of the study group and treated with a short steroid regimen will be retrospectively analysed and compared

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

June 30, 2011

Last Update Submit

July 19, 2021

Conditions

Nephrotic Syndrome

Keywords

Nephrotic SyndromeSteroid treatmentProteinuriaChild

Study Arms (1)

Study group

children aged 6 months - 18 years, diagnosed with an initial episode of INS occurring from the first of July 2011 to the 31st of june 2013.

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged 6 months - 18 years, diagnosed with an initial episode of idiopathic nephrotic syndrome (proteinuria\> 40mg/m2/h or urine protein/creatine ratio \> 2 mg/mg and hypoalbuminemia \<2.5g/dL). Subjects will be enrolled from the first of July 2011 to the 31st of June 2013 from the following Italian regions Emilia Romagna, Lombardia, Toscana, Trentino Alto Adige, Friuli Venezia Giulia, Marche and Sicilia; the follow-up of each subject will continue for 24 months.

You may qualify if:

  • Age \> 6 months and\< 18 years
  • Idiopathic nephrotic syndrome
  • Ethical committee approval

You may not qualify if:

  • Age \< 6 months or \> 18 years
  • Congenital nephrotic syndrome
  • Secondary nephrotic syndrome (post-infectious, SLE, Schonlein-Henoch) defined by clinical features, low C3 and C4 levels, severe hypertension and macrohematuria
  • nephrotic syndrome associated to other syndromes (Dennys Drash, Frasier syndrome, et.cet) or to Wilms'tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

PO Salesi, SOS Centro di Riferimento Regionale di Nefrologia e Dialisi Pediatrica

Ancona, Italy

Location

Ospedale Pediatrico Giovanni XXIII

Bari, 70126, Italy

Location

Azienda Ospedaliera Universitaria Meyer, SOD Complessa Nefrologia Pediatrica

Florence, Italy

Location

Istituto Giannina Gaslini, Dept of Pediatric Nephrology

Genova, 16100, Italy

Location

AOU Policlinico G Martino UOS dipartimentale Nefrologia e Reumatologia pediatrica

Messina, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale MAggiore Policlinico, UOC Nefrologia e Dialisi

Milan, Italy

Location

Ospedale dei bambini Di Cristina, UOC Nefrologia Pediatrica

Palermo, Italy

Location

Ospedale degli Angeli, Dept of Pediatrics

Pordenone, 33170, Italy

Location

Ospedale Pediatrico Burlo Garofalo

Trieste, Italy

Location

Università di Trieste, Department of Life Sciences

Trieste, Italy

Location

Related Publications (3)

  • Nardini B, La Scola C, Corrado C, Edefonti A, Giordano M, Pillon R, Mastrangelo AP, Materassi M, Alberici I, Morello W, Puccio G, Montini G, Pasini A. Time to remission in childhood steroid sensitive nephrotic syndrome: a change in perspective. Eur J Pediatr. 2025 Mar 20;184(4):262. doi: 10.1007/s00431-025-06090-z.

    PMID: 40111516DERIVED

  • Pasini A, Bertulli C, Casadio L, Corrado C, Edefonti A, Ghiggeri G, Ghio L, Giordano M, La Scola C, Malaventura C, Maringhini S, Mastrangelo AP, Materassi M, Mencarelli F, Messina G, Monti E, Morello W, Puccio G, Romagnani P, Montini G; NefroKid Study Group. Childhood Idiopathic Nephrotic Syndrome: Does the Initial Steroid Treatment Modify the Outcome? A Multicentre, Prospective Cohort Study. Front Pediatr. 2021 Jul 8;9:627636. doi: 10.3389/fped.2021.627636. eCollection 2021.

    PMID: 34307246DERIVED

  • Pasini A, Aceto G, Ammenti A, Ardissino G, Azzolina V, Bettinelli A, Cama E, Cantatore S, Crisafi A, Conti G, D'Agostino M, Dozza A, Edefonti A, Fede C, Groppali E, Gualeni C, Lavacchini A, Lepore M, Maringhini S, Mariotti P, Materassi M, Mencarelli F, Messina G, Negri A, Piepoli M, Ravaglia F, Simoni A, Spagnoletta L, Montini G; NefroKid Study Group. Best practice guidelines for idiopathic nephrotic syndrome: recommendations versus reality. Pediatr Nephrol. 2015 Jan;30(1):91-101. doi: 10.1007/s00467-014-2903-7. Epub 2014 Aug 17.

    PMID: 25127916DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood and Urine

MeSH Terms

Conditions

Nephrotic SyndromeProteinuria

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Montini, MD

    Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, Bologna, Italy

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 1, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

IT(11)