Minimal Change Nephrotic Syndrom
Conditions
Brief summary
Incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission
Detailed description
The relapse rate at 18 months of follow-up after randomization, The type, frequency and the severity of adverse events (AEs) and serious adverse events (SAEs), The treatment burden assessed with the Treatment Burden Questionnaire, To assess potential risk factors of relapse, the following explanatory variables will be recorded (demographics, clinical characteristics, biological variables, renal pathologic findings)
Interventions
DRUGPREDNISOLONE
DRUGPREDNISONE
DRUGMabThera 500 mg concentrate for solution for infusion
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission | — |
Secondary
| Measure | Time frame |
|---|---|
| The relapse rate at 18 months of follow-up after randomization, The type, frequency and the severity of adverse events (AEs) and serious adverse events (SAEs), The treatment burden assessed with the Treatment Burden Questionnaire, To assess potential risk factors of relapse, the following explanatory variables will be recorded (demographics, clinical characteristics, biological variables, renal pathologic findings) | — |
Countries
France
Outcome results
None listed