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Can a targeted antibody tame kidney inflammation without heavy steroids?

NCT ID NCT07746180

Disease control Sponsor: Chinese PLA General 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether a new drug called obinutuzumab beta, combined with a short course of steroids, can help people with newly diagnosed ANCA-associated glomerulonephritis—a rare autoimmune disease that causes kidney inflammation and damage. The study will enroll 20 participants who will receive the drug intravenously along with oral steroids that are quickly tapered off. The main goal is to see how many achieve complete remission, meaning no signs of active disease and no need for steroids.

What this could mean

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

Active substance
Obinutuzumab beta (MIL62) combined with a rapid-tapering oral glucocorticoid regimen
What this could lead to
If successful, this combination could offer a new treatment option for ANCA-associated glomerulonephritis, potentially achieving remission with less steroid exposure and fewer side effects.
What could go wrong
This is a small, early-phase exploratory study, so results may not be conclusive or generalizable. The treatment may not be effective or could cause serious side effects, including infections or infusion reactions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Started

Aug 2026

Expected to finish

Mar 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 years and older

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: * New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis \[GPA\] or Microscopic polyangiitis \[MPA\]) according to the Chapel Hill Consensus Conference definitions. * Positive for PR3-ANCA or MPO-ANCA. * Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and/or crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria. * Provided signed informed consent. Exclusion Criteria: * Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV. * Current requirement for dialysis, or history of dialysis. * Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis). * History of malignancy within the past 5 years. * Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease). * Active severe infections, active tuberculosis, or chronic viral infections (HBV with positive HBsAg or HBV-DNA, active HCV, HIV). * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis pauci-immune glomerulonephritis with ANCA

As listed by the trial registrant

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

ANCA-associated glomerulonephritis (AAGN) ANCA-associated vasculitis (AAV)

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

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, China

More trials for these conditions

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