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Steroid Treatment of Idiopathic Nephrotic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Collaborators:
IL Sogno di Stefano
Nando Peretti Foundation
Information provided by (Responsible Party):
Giovanni Montini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01386957
First received: June 30, 2011
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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. Study group: children aged 6 months - 18 years, diagnosed with an initial episode of idiopathic nephrotic syndrome
  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

Condition
Nephrotic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Steroid Treatment of Childhood Idiopathic Nephrotic Syndrome: Epidemiology, Therapeutic Adequacy, Medium and Long Term Outcomes. A Prospective Observational Cohort Study.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Biospecimen Retention:   Samples Without DNA

Whole Blood and Urine


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  1. Age > 6 months and< 18 years
  2. Idiopathic nephrotic syndrome
  3. Ethical committee approval

Exclusion Criteria:

  1. Age < 6 months or > 18 years
  2. Congenital nephrotic syndrome
  3. Secondary nephrotic syndrome (post-infectious, SLE, Schonlein-Henoch) defined by clinical features, low C3 and C4 levels, severe hypertension and macrohematuria
  4. nephrotic syndrome associated to other syndromes (Dennys Drash, Frasier syndrome, et.cet) or to Wilms'tumor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386957

Contacts
Contact: montini giovanni, MD +390516364617 giovanni.montini@aosp.bo.it
Contact: pasini andrea, MD +390516364334 andrea.pasini@aosp.bo.it

Locations
Italy
Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi Recruiting
Bologna, Emilia Romagna, Italy, 40138
Contact: Giovanni Montini, MD       giovanni.montini@aosp.bo.it   
Sub-Investigator: Andrea Pasini, MD         
PO Salesi, SOS Centro di Riferimento Regionale di Nefrologia e Dialisi Pediatrica Not yet recruiting
Ancona, Italy
Contact: Ilse Ratsch, MD       ilsemaria.r@gmail.com   
Ospedale Pediatrico Giovanni XXIII Recruiting
Bari, Italy, 70126
Contact: Giovanni Messina, MD    +390805596803    giovanni.messina1952@libero.it   
Principal Investigator: Giovanni Messina, MD         
Azienda Ospedaliera Universitaria Meyer, SOD Complessa Nefrologia Pediatrica Recruiting
Firenze, Italy
Contact: Marco Materassi, MD       m.materassi@meyer.it   
Principal Investigator: Marco Materassi, MD         
Istituto Giannina Gaslini, Dept of Pediatric Nephrology Recruiting
Genova, Italy, 16100
Contact: Gianmarco Ghiggeri, MD    +39010 380742    GMarcoGhiggeri@ospedale-gaslini.ge.it   
Principal Investigator: Gianmarco Ghiggeri, MD         
AOU Policlinico G Martino UOS dipartimentale Nefrologia e Reumatologia pediatrica Not yet recruiting
Messina, Italy
Contact: Giovanni Conti, MD       giovanniconti@hotmail.com   
Principal Investigator: Giovanni Conti, MD         
Fondazione IRCCS Ca' Granda Ospedale MAggiore Policlinico, UOC Nefrologia e Dialisi Recruiting
Milano, Italy
Contact: Alberto Edefonti, MD       aedefonti@hotmail.com   
Sub-Investigator: Luciana Ghio, MD         
Sub-Investigator: Gianluigi Ardissino, MD         
Ospedale dei bambini Di Cristina, UOC Nefrologia Pediatrica Not yet recruiting
Palermo, Italy
Contact: Silvio Maringhini, MD       s.maringhini@ospedalecivicopa.org   
Principal Investigator: Silvio Maringhini, MD         
Ospedale degli Angeli, Dept of Pediatrics Not yet recruiting
Pordenone, Italy, 33170
Contact: Roberto Dall'Amico, MD       roberto.dallamico@aopn.fvg.it   
Principal Investigator: Roberto Dall'Amico, MD         
Ospedale Pediatrico Burlo Garofalo Recruiting
Trieste, Italy
Contact: Marco Pennesi, MD       pennesi@burlo.trieste.it   
Sub-Investigator: Ines L'Erario, MD         
Università di Trieste, Department of Life Sciences Not yet recruiting
Trieste, Italy
Contact: Giuliana De Corti, MD       decorti@units.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IL Sogno di Stefano
Nando Peretti Foundation
Investigators
Study Chair: Giovanni Montini, MD Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi, Bologna, Italy
  More Information

No publications provided

Responsible Party: Giovanni Montini, MD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01386957     History of Changes
Other Study ID Numbers: SNI-NET 2011
Study First Received: June 30, 2011
Last Updated: March 7, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Nephrotic Syndrome
Steroid treatment
Proteinuria
Child

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrotic Syndrome
Syndrome
Disease
Kidney Diseases
Nephrosis
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014