소아 스테로이드 의존성 및 빈번한 재발성 신증후군에서 Obinutuzumab과 Rituximab의 효능 및 안전성 (OBIRINS)

Inclusion Criteria:

• Age between 3 and 18 years

• Steroid dependant Nephrotic Syndrome defined as:

  • 2 or more relapses during steroids or within 2 weeks following discontinuation.
  • 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal

OR Frequent Relapsing Nephrotic Syndrome defined as:

• 2 or more relapses within 6 months following first remission

• 3 or more relapses within any 12-month period

  • Last relapse within 3 months prior to inclusion
  • In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
  • Vaccination schedule in accordance with the current recommendations in France
  • Informed consent from parents

Exclusion Criteria:

• Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
• Primary or secondary steroid resistance nephrotic syndrome
• Prior treatment with Rituximab within 6 months
• Prior treatment with obinutuzumab at any time
• CD20+ B-cell count < 2.5%
• Patient with neutrophils < 1.5 G/L and/or platelets < 75 G/L
• GFR < 80 ml/min/1.73m2
• Weight <16kg
• History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
• History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
• Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
• Known hyperprolinemia
• Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
• Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
• Patient without medical insurance coverage (beneficiary or legal)