A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients

A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)

This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients

INCLUSION CRITERIA：

1. Signed Informed Consent Form
2. Age 18 to 65 years at time of signing Informed Consent Form
3. Ability to comply with the study protocol, in the investigator's judgment
4. ISN/RPS 2003 Class III, IV, V active/active chronic LN by renal biopsy performed within the 1 month prior to screening or during screening with 24hUPCR≥1g/g
5. SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III- V LN or mixed Class LN, and current or past positive antinuclear antibody (ANA) Positive ANA is defined by ANA at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive ANA test at least once.
6. Receipt of at least one dose of pulse methylprednisolone IV (≥250 mg) or equivalent for treatment of the current episode of active LN during the 1 month prior to screening or during screening
7. A maximum of 3 g methylprednisolone IV or equivalent d during the 4 weeks prior to screening or during screening is allowed.

EXCLUSION CRITERIA：

1. Are pregnant or breastfeeding.
2. Have severe renal impairment, defined as eGFR < 30 mL/min/1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation.
3. Have renal biopsy showing > 50% glomerular sclerosis.
4. Have pure chronic renal biopsy findings: no active lesions.
5. Have rapidly progressive glomerulonephritis.
6. Have active gastrointestinal ulcer.
7. Have intolerance or contraindication to the study treatment.