Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02455908
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2015-05-13
Brief Title:
IL-2 for Multi Drug Resistant Nephrotic Syndrome
Sponsor:
Istituto Giannina Gaslini
Organization:
Istituto Giannina Gaslini
Study Overview
Official Title:
Use of IL-2 for Pediatric Multi Drug Resistant Idiopathic Nephrotic Syndrome
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 Proleukin in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs steroids calcineurin inhibitors Rituximab following the therapeutical scheme indicated for crioglobulinemic nephropathy
cycle1 IL2 1x106 m2 sc for 5 consecutive days cycle2 IL2 15 x106 m2 sc for 5 consecutive days starting from 3 weeks after the first cycle
cycle3 IL2 15 x106 m2 sc for 5 consecutive days starting from 6 weeks after the first cycle
Cycle 4 IL2 15 x106 m2 sc for 5 consecutive days starting from 9 weeks after the first cycle
Current therapy with steroids and calcineurin inhibitors Prograf will be maintained during the first cycle and progressively reduced during the subsequent cycles
The first cycle will be performed during hospitalization in the investigators Unit subsequent cycles will be performed at nephrology outpatients All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol together with specific cellular values Tregs B cells NK
cycle1 IL2 1x106 m2 sc for 5 consecutive days cycle2 IL2 15 x106 m2 sc for 5 consecutive days starting from 3 weeks after the first cycle
cycle3 IL2 15 x106 m2 sc for 5 consecutive days starting from 6 weeks after the first cycle
Cycle 4 IL2 15 x106 m2 sc for 5 consecutive days starting from 9 weeks after the first cycle
Current therapy with steroids and calcineurin inhibitors Prograf will be maintained during the first cycle and progressively reduced during the subsequent cycles
The first cycle will be performed during hospitalization in the investigators Unit subsequent cycles will be performed at nephrology outpatients All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol together with specific cellular values Tregs B cells NK
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None