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Kidney disease drug may train immune cells to calm themselves

NCT ID NCT07811557

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Membranous nephropathy is a rare autoimmune kidney disease where antibodies attack the kidney and can cause nephrotic syndrome. Rituximab is a routine treatment that depletes B cells, but researchers suspect it also boosts regulatory T cells, which help control immune reactions. In this pilot study, 12 adults with active anti-PLA2R1-positive membranous nephropathy who are already scheduled for rituximab give extra blood samples before treatment and six months later. Scientists use single-cell RNA sequencing to track changes in immune cells and test candidate signaling pathways in the lab.

What this could mean

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

Active substance
rituximab, a drug that depletes B cells
What this could lead to
If the study identifies how rituximab prompts regulatory T cells, researchers could design better treatments for membranous nephropathy and other autoimmune diseases.
What could go wrong
This is a small pilot study of 12 people at one center, so its findings may not apply broadly. It measures immune-cell changes, not whether patients improve.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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: 1. Signed informed consent. 2. Anti-PLA2R1-positive membranous nephropathy. 3. Active nephrotic syndrome, defined as urinary protein/creatinine ratio \>3.5 g/g and serum albumin \<30 g/L. 4. Indication for rituximab treatment as part of routine care. 5. Estimated glomerular filtration rate calculated using the CKD-EPI equation \>30 mL/min/1.73 m2. Exclusion Criteria: 1. Lack of affiliation to the French social security system. 2. Vulnerable person, including minors, adults under guardianship or curatorship, pregnant women, persons deprived of liberty, or persons who do not master the French language. 3. Immunosuppressive treatment received within the previous 6 months. 4. Breastfeeding. 5. Absence of effective contraception, when applicable. 6. Premature discontinuation before administration of both rituximab infusions. 7. Voluntary withdrawal of informed consent or objection to the use of study data or biological samples.

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis nephrotic syndrome

As listed by the trial registrant

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

Membranous nephropathy Membranous nephropathy - PLA2R induced Nephrotic syndrome

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • CHU de NICE

    Nice, 06200, France

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