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

August 24, 2026 updated by: Zhao Minghui

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
      • Guangzhou, Guangdong, China
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
        • Contact:
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Chief Physician
          • Phone Number: +86 138 7919 0111
    • Liaoning
      • Shenyang, Liaoning, China
    • Shandong
      • Yantai, Shandong, China
        • Yantai YuHuangDing Hospital
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Luzhou, Sichuan, China
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
          • Chief Physician
          • Phone Number: +86 13679676835
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University General Hospita
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: O-triple therapy
Obinutuzumab add on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids (O-triple) in initial active LN patients.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who achieve a complete renal response (CRR) at Week 76
Time Frame: 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).
Baseline, Week 76

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients who achieve ORR (CRR or PRR), CRR, PRR, PERR at week 24, week 36, week 52, week 76
Time Frame: Baseline week 24, week 36, week 52, week 76
Baseline week 24, week 36, week 52, week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhao Minghui

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

February 27, 2029

Study Completion (Estimated)

May 8, 2029

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026R0300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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