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Can a targeted antibody boost kidney remission in lupus?

NCT ID NCT07767188

Disease control Sponsor: Zhao Minghui Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This phase 3 trial is testing whether adding the drug obinutuzumab to the standard treatment (mycophenolate mofetil and corticosteroids) can improve outcomes for people with active lupus nephritis, a serious kidney complication of lupus. The study will enroll 70 adults aged 18-65 with confirmed active lupus nephritis. Participants will receive obinutuzumab infusions at specified intervals over a year, alongside standard therapy. The main goal is to see how many achieve a complete renal response by week 76, meaning their kidney function stabilizes and protein in the urine drops to a healthy level.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obinutuzumab
What this could lead to
If successful, this could lead to a new first-line treatment option for lupus nephritis that improves kidney outcomes.
What could go wrong
This is a single-arm trial without a placebo control, so results may be influenced by the standard therapy alone. Obinutuzumab can have side effects, including infusion reactions and increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Peking University First Hospital

    Beijing, China

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, China

  • Tianjin Medical University General Hospita

    Tianjin, Tianjin Municipality, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.