Lupus NephritisPhase 3NCT07767188
A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)
A Phase 3 study testing obinutuzumab (RO5072759) in people with Lupus Nephritis, run by Zhao Minghui at 14 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- obinutuzumab (RO5072759)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 14 sitesChina
- Study dates
- 10 Sep 2026to 8 May 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites
Peking University First Hospital
Beijing
Fujian Medical University Union Hospital
Fuzhou, Fujian
Chief Physician, +86 18050288838, lixinwei66@126.com
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Chief Physician, 15820264379@139.com
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Chief Physician, +86 13189097222, longhb1966@163.com
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Chief Physician, +86 15776613376, suimanshu@163.com
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Chief Physician, +86 13679676835
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Chief Physician, +86 138 7919 0111
Jiangsu Province Hospital
Nanjing, Jiangsu
Chief Physician, +86 13851746819, huijuanmao2026@163.com
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning
Chief Physician, huazhou_clintrial@163.com
Tianjin Medical University General Hospita
Tianjin, Tianjin Municipality
Chief Physician, nkxpc@163.com
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Chief Physician, +86 13579416340, lisuhuanh@sina.com
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Chief Physician, 15291185506, pipifu@126.com
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Chief Physician, +86 15862158578, sundongxz@126.com
Yantai Yuhuangding Hospital
Yantai, Shandong
Chief Physician, 18663819062, wudaoxu@qdu.edu.cn
About this study
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)
This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients
- Conditions
- Lupus Nephritis
- Being tested
- obinutuzumab (RO5072759)
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obinutuzumab (RO5072759)Drug
Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
| Study group | Role | What they receive |
|---|---|---|
| O-triple therapy | Experimental | Obinutuzumab add on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids (O-triple) in initial active LN patients. Receives: Drug: obinutuzumab (RO5072759) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Baseline week 24, week 36, week 52, week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion27 Feb 2029 (estimated)
- Study completion8 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhao Minghui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhao Minghui, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767188
- Sponsor's protocol ID
- 2026R0300
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes