obinutuzumab (RO5072759): Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
Study summary
This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of patients who achieve a complete renal response (CRR) at Week 76 — Baseline, 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).
Trial sites (14)
Facility
City
Region
Status
Fujian Medical University Union Hospital
Fuzhou
Fujian
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou
Guangdong
The First Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Jiangsu Province Hospital
Nanjing
Jiangsu
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Shengjing Hospital affiliated to China Medical University
Shenyang
Liaoning
Yantai Yuhuangding Hospital
Yantai
Shandong
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
The Affiliated Hospital of Southwest Medical University
Luzhou
Sichuan
Tianjin Medical University General Hospita
Tianjin
Tianjin Municipality
The First Affiliated Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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