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Not yet taking people in ChinaPhase 3

Obinutuzumab added to standard treatment for newly active lupus nephritis

Tests obinutuzumab plus usual medicines in adults with newly active lupus nephritis.

Plain-language title generated from the registry record
Registry title: A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)

Key facts

Where
Beijing, Fuzhou, Guangzhou, Harbin, Luzhou, Nanchang, Nanjing, Shenyang, Tianjin, Ürümqi, Xi'an, Xuzhou, and Yantai, ChinaSee the 14 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with newly active lupus nephritis (lupus kidney disease), confirmed by a kidney biopsy. Everyone receives obinutuzumab together with mycophenolate mofetil and corticosteroids.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Active lupus nephritis, ISN/RPS 2003 Class III, IV or V (active or active chronic) on kidney biopsy, with systemic lupus erythematosus (SLE) and 24hUPCR≥1g/g.
Earlier treatment
Must have had at least one dose of pulse methylprednisolone IV (≥250 mg) or equivalent for the current episode. A maximum of 3 g methylprednisolone IV or equivalent is allowed in the 4 weeks before screening or during screening.
Biomarker or test result
Current or past positive antinuclear antibody (ANA) test, at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive test, at least once.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Severe kidney impairment (eGFR < 30 mL/min/1.73 m²), or needing dialysis or kidney transplant
  • Kidney biopsy with > 50% glomerular sclerosis
  • Only chronic biopsy findings with no active lesions
  • Rapidly progressive glomerulonephritis

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07767188, who can take part

Where in China

  • Peking University First HospitalBeijing, ChinaNo longer taking part
  • Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
  • Guangdong Provincial People's HospitalGuangzhou, ChinaNo longer taking part
  • Zhujiang Hospital of Southern Medical UniversityGuangzhou, ChinaNo longer taking part
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaNo longer taking part
  • The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaNo longer taking part
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaNo longer taking part
  • Jiangsu Province HospitalNanjing, ChinaNo longer taking part
  • Shengjing Hospital affiliated to China Medical UniversityShenyang, ChinaNo longer taking part
  • Tianjin Medical University General HospitaTianjin, ChinaNo longer taking part
  • The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaNo longer taking part
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNo longer taking part
  • The affiliated hospital of xuzhou medical universityXuzhou, ChinaNo longer taking part
  • Yantai Yuhuangding HospitalYantai, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Zhao Minghui
Trial code
NCT07767188
Record updated
26 August 2026
Original description
This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patientsRead full original descriptionShow less

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

Inclusion: 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.

Exclusion: Have active gastrointestinal ulcer; 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; Are pregnant or breastfeeding; Have renal biopsy showing > 50% glomerular sclerosis; Have pure chronic renal biopsy findings: no active lesions; Have rapidly progressive glomerulonephritis; Have intolerance or contraindication to the study treatment.

ClinicalTrials.gov NCT07767188