Steroid Treatment of Idiopathic Nephrotic Syndrome
This study is currently recruiting participants.
Verified March 2012 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
- Study group: children aged 6 months - 18 years, diagnosed with an initial episode of idiopathic nephrotic syndrome
- 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. |
Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Biospecimen Retention: Samples Without DNA
Show Detailed Description
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:
- Age > 6 months and< 18 years
- Idiopathic nephrotic syndrome
- Ethical committee approval
Exclusion Criteria:
- 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.
Contacts and Locations
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 | |
| Università di Trieste, Department of Life Sciences | Not yet recruiting |
| Trieste, Italy | |
| Contact: Giuliana De Corti, MD decorti@units.it | |
| Ospedale Pediatrico Burlo Garofalo | Recruiting |
| Trieste, Italy | |
| Contact: Marco Pennesi, MD pennesi@burlo.trieste.it | |
| Sub-Investigator: Ines L'Erario, MD | |
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 Nephrosis Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013