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AI boosts kidney drug dosing: hope for membranous nephropathy patients

NCT ID NCT06341205

Disease control Sponsor: Centre Hospitalier Universitaire de Nice 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether artificial intelligence can help doctors personalize rituximab doses for people with membranous nephropathy, an autoimmune kidney disease. About 120 adults with active disease will receive either standard rituximab or AI-guided dosing to keep drug levels high enough. The goal is to see if personalized dosing leads to more remissions after 6 months.

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 120 people

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

Started

Feb 2025

Expected to finish

Sep 2031

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: * Age ≥ 18 years * Ongoing episode of membranous nephropathy diagnosed by the presence of anti-PLA2R1 antibodies detected by ELISA (≥ 14 RU/ml, EUROIMMUN): the result must be validated by the Coordination team before randomization. * Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis * Estimated Glomerular Filtration Rate (CKD-EPI formula) \> 30 mL/min/1,73 m2 * Indication for rituximab treatment according to the KDIGO and French guidelines * Non-immunosuppressive antiproteinuric treatment at stable dose for 2 weeks according to French guidelines, including a renin angiotensin aldosterone system inhibitor, a diuretic and a low-salt diet at maximal tolerated dose (i.e., absence of orthostatic hypotension and no increase in creatinine \> 30%) Exclusion Criteria: * Secondary Membranous nephropathy related to cancer, infection, systemic lupus, drug * Diagnosis of PLA2R1-associated Membranous nephropathy not confirmed by the Coordination team (validation mandatory for randomization) * Pregnancy or breastfeeding * Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion * Presence of anti-rituximab antibodies detected by Central Lab * Cancer under treatment * Patients with active, severe infections * Hypersensitivity to the active substance or excipients * Patients severely immunocompromised * Severe heart failure or severe, uncontrolled cardiac disease

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Conditions

The condition(s) this trial relates to.

membranous glomerulonephritis

As listed by the trial registrant

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

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

    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

  • AP-HM - Hôpital de la Conception

    RECRUITING

    Marseille, France

  • AP-HP - Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • AP-HP - Hôpital H. Mondor

    RECRUITING

    Créteil, France

  • AP-HP - Hôpital Necker

    RECRUITING

    Paris, France

  • CH de Valenciennes

    RECRUITING

    Valenciennes, France

  • CHRU de TOURS - Hôpital Bretonneau

    RECRUITING

    Tours, France

  • CHU de BESANCON

    RECRUITING

    Besançon, France

  • CHU de BORDEAUX - Hôpital Pellegrin

    RECRUITING

    Bordeaux, France

  • CHU de CAEN

    RECRUITING

    Caen, France

  • CHU de NICE

    RECRUITING

    Nice, France

  • CHU de Nîmes - Hôpital CAREMEAU

    RECRUITING

    Nîmes, France

  • CHU de TOULOUSE - Hôpital Rangueil

    RECRUITING

    Toulouse, France

  • HCL - Hôpital E. Herriot

    RECRUITING

    Lyon, France

  • Hôpital Tenon

    NOT_YET_RECRUITING

    Paris, France

More trials for these conditions

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