This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients
Signed Informed Consent Form
Age 18 to 65 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator's judgment
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
Are pregnant or breastfeeding.
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.
Have renal biopsy showing > 50% glomerular sclerosis.
Have pure chronic renal biopsy findings: no active lesions.
Single group
obinutuzumab (RO5072759)
DrugPatients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
Proportion of patients who achieve a complete renal response (CRR) at Week 76
Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g eGFR ≥ 85% of baseline, as calculated using the CKD-EPI equation No occurrence of intercurrent events (rescue therapy, treatment failure, and early study withdrawal are considered as intercurrent events).
The proportion of patients who achieve ORR (CRR or PRR), CRR, PRR, PERR at week 24, week 36, week 52, week 76
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Zhao Minghui
Lead sponsor
Peking University First Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
