A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)
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)
1 other identifier
interventional
70
1 country
14
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2026
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2026
CompletedFirst Posted
Study publicly available on registry
August 17, 2026
CompletedStudy Start
First participant enrolled
September 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2029
Study Completion
Last participant's last visit for all outcomes
May 8, 2029
August 26, 2026
August 1, 2026
2.5 years
August 11, 2026
August 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline, Week 76
Secondary Outcomes (1)
The proportion of patients who achieve ORR (CRR or PRR), CRR, PRR, PERR at week 24, week 36, week 52, week 76
Baseline week 24, week 36, week 52, week 76
Study Arms (1)
O-triple therapy
EXPERIMENTALObinutuzumab add on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids (O-triple) in initial active LN patients.
Interventions
Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
Eligibility Criteria
You may qualify if:
- 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
- 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.
- 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
- A maximum of 3 g methylprednisolone IV or equivalent d during the 4 weeks prior to screening or during screening is allowed.
You may not qualify if:
- 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.
- Have rapidly progressive glomerulonephritis.
- Have active gastrointestinal ulcer.
- Have intolerance or contraindication to the study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhao Minghuilead
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2026
First Posted
August 17, 2026
Study Start (Estimated)
September 10, 2026
Primary Completion (Estimated)
February 27, 2029
Study Completion (Estimated)
May 8, 2029
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF