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NOT YET RECRUITING
NCT07767188
PHASE3

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

Sponsor: Zhao Minghui

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-09-10

Completion Date

2029-05-08

Last Updated

2026-08-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

Locations (14)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

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

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Tianjin Medical University General Hospita

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Peking University First Hospital

Beijing, China