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Not yet recruitingNCT07767188Updated Aug 26, 2026

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 interventional study of obinutuzumab (RO5072759) in Lupus Nephritis, sponsored by Zhao Minghui. Not yet recruiting at 14 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Zhao Minghui · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 95 studies in Lupus Nephritis with a site in China — 42 open to participants now, 45 under way, 8 of them phase 3. Lupus Nephritis · China.

Planned enrollment
37th of 87
70 · median 50
Started
2026
with 9 others
Phase 3
20 of 95
6 open now
Primary completion
2029-02
later than 39 of 44 live
Registered
94th of 95
by date

Among the 95 studies in Lupus Nephritis with a site in China, this one is the 37th largest by planned enrollment of the 87 interventional ones that give a count, is one of 10 that started in 2026, is one of 20 in phase 3, reaches primary completion later than 39 of the 44 other live ones, and was the 94th registered.

Lupus Nephritis

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

Browse Lupus Nephritis studies →

Open to participants now

42 of the 95 studies in Lupus Nephritis with a site in China are open now. Recruiting first, the newest first:

37 more — sign in →

All 42 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Lupus Nephritis

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed 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 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

EXCLUSION CRITERIA:

  1. Are pregnant or breastfeeding.
  2. Have severe renal impairment, defined as \< 30 mL/min/1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation.
  3. Have renal 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 to the study treatment.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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)

Interventions

  • Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.

06

What researchers measure

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).

    Time frame: 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

    Time frame: Baseline week 24, week 36, week 52, week 76

07

Study locations

14 sites
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Feb 2029, 29 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 17, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Feb 27, 2029
CompletionEst.
May 8, 2029
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767188
Lead sponsor
Zhao Minghui
Responsible party
Zhao Minghui (Professor, Peking University First Hospital) — Sponsor-investigator
First posted
Aug 17, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Feb 27, 2029 (estimated)
Completion
May 8, 2029 (estimated)
Last update
Aug 26, 2026

Study contacts

Minghui Zhao
Contact
mhzhao@bjmu.edu.cn
+86 135 0124 3815

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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