Nephrotic Syndrome Clinical Trial
Official title:
Use of IL-2 for Pediatric, Multi Drug Resistant, Idiopathic Nephrotic Syndrome
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 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5
consecutive days, starting from 3 weeks after the first cycle.
cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first
cycle.
Cycle 4: IL2 1.5 x106 /m2 s.c 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).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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