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New hope for kidney patients: targeted drug may replace harsh chemotherapy

NCT ID NCT06781944

Disease control Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares a newer targeted drug, obinutuzumab, against a standard treatment (cyclophosphamide plus steroids) for primary membranous nephropathy, a kidney disease that can lead to kidney failure. About 144 adults with moderate to severe protein in their urine will receive either obinutuzumab infusions or the standard regimen. The goal is to see if obinutuzumab can achieve better remission rates with fewer side effects.

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, obinutuzumab could offer a more effective and less toxic treatment option for people with primary membranous nephropathy, potentially reducing the need for harsh chemotherapy-like drugs.
What could go wrong
This is a Phase 3 trial, but it is still early to know if obinutuzumab is truly better or safer than the current standard. The study is open-label, which can introduce bias, and long-term outcomes are not yet known.

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 144 people

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

Started

Oct 2024

Expected to finish

May 2028

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 75 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: * Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form * pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU/ml ) * 24-hour UPCR ≥ 4 g/g and serum albumin (sALB) \< 30 g/L,despite being treated with ACEi and/or ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g/g and sALB \< 30 g/L , despite being treated with ACEi and/or ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g/g and sALB \< 25 g/L, despite being treated with ACEi and/or ARB for ≥ 1 month prior to screening,. * eGFR ≥40 mL/min/1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR \<60mL/min/1.73 m2. * Ability to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies) * Type 1 or 2 diabetes mellitus * eGFR \<40 mL/min/1.73m2 (CKD-EPI) or dialysis or kidney transplantation * Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

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

Primary membranous nephropathy

How to take part

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

  1. The places running it

    1 site. 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

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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