Idiopathic Nephrotic Syndrome
Conditions
Brief summary
Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
Detailed description
Time to protein increase to >3.5g/24H and/or P/C>3500 mg/g along with serum albumin <3.5 g/dl, Time to B-cell increase to > 5cells/mm3, Changes in Serum creatinine level, urea, eGFR (by CKD-Epi equation) and mGFR (measured at 6 and 12 months by the iohexol plasma clearance techniques)., Changes in hematologic parameters (serum total protein, albumin, total, LDL and HDl cholesterol, triglycerides) and in urine parameters (24-hour proteinuria and albuminuria) along with edema and body weight, Changes in total protein, albumin and IgG fractional clearances, Changes in participant health-related quality of life as measured by means of the SF-12 questionnaire
Interventions
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
Sponsors
Istituto Di Ricerche Farmacologiche Mario Negri
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who are relapse-free for 12 months after Obinutuzumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to protein increase to >3.5g/24H and/or P/C>3500 mg/g along with serum albumin <3.5 g/dl, Time to B-cell increase to > 5cells/mm3, Changes in Serum creatinine level, urea, eGFR (by CKD-Epi equation) and mGFR (measured at 6 and 12 months by the iohexol plasma clearance techniques)., Changes in hematologic parameters (serum total protein, albumin, total, LDL and HDl cholesterol, triglycerides) and in urine parameters (24-hour proteinuria and albuminuria) along with edema and body weight, Changes in total protein, albumin and IgG fractional clearances, Changes in participant health-related quality of life as measured by means of the SF-12 questionnaire | — |
Outcome results
None listed