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Steroid Treatment of Idiopathic Nephrotic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Recruiting
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   (Child, Adult)
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

Locations
Italy
Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi
Bologna, Emilia Romagna, Italy, 40138
PO Salesi, SOS Centro di Riferimento Regionale di Nefrologia e Dialisi Pediatrica
Ancona, Italy
Ospedale Pediatrico Giovanni XXIII
Bari, Italy, 70126
Azienda Ospedaliera Universitaria Meyer, SOD Complessa Nefrologia Pediatrica
Firenze, Italy
Istituto Giannina Gaslini, Dept of Pediatric Nephrology
Genova, Italy, 16100
AOU Policlinico G Martino UOS dipartimentale Nefrologia e Reumatologia pediatrica
Messina, Italy
Fondazione IRCCS Ca' Granda Ospedale MAggiore Policlinico, UOC Nefrologia e Dialisi
Milano, Italy
Ospedale dei bambini Di Cristina, UOC Nefrologia Pediatrica
Palermo, Italy
Ospedale degli Angeli, Dept of Pediatrics
Pordenone, Italy, 33170
Ospedale Pediatrico Burlo Garofalo
Trieste, Italy
Università di Trieste, Department of Life Sciences
Trieste, Italy
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Syndrome
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016