This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
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).
Time frame: Baseline, Week 76
The proportion of patients who achieve ORR (CRR or PRR), CRR, PRR, PERR at week 24, week 36, week 52, week 76
Time frame: Baseline week 24, week 36, week 52, week 76
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Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
...and 4 more locations