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Clinical Trials in China / NCT07767188
Starting soon Phase 3

A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)

NCT07767188 · tracked via the Priya Life Science China tracker
Sponsor
Zhao Minghui
Phase
Phase 3
Started
2026-09-10
Last updated
2026-08-26

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

obinutuzumab (RO5072759)

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)

Trial sites (14)

FacilityCityRegionStatus
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 Ürümqi Xinjiang
Peking University First Hospital Beijing China

Other trials for the same condition

Official registry record

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.

View NCT07767188 on ClinicalTrials.gov ↗ ← All trials in China