Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for young lupus patients: drug trial targets kidney damage

NCT ID NCT05039619

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 5 times

Summary

This study tests if obinutuzumab can help teens and children with lupus nephritis, a serious kidney complication of lupus. About 40 participants aged 5 to 17 will receive either the drug or a placebo. The goal is to see if the drug improves kidney function and reduces protein in urine, while monitoring safety.

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 40 people

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

Started

May 2022

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

5 to 17 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: * Participants who are age 12 to \<18 years at the time of randomization * Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population) * International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening * Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible * Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria * Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening * During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN. Exclusion Criteria: * Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia * Sclerosis in \>50% of glomeruli on renal biopsy * Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions * Presence of rapidly progressive glomerulonephritis * Pure Class V LN * Intolerance or contraindication to study therapies * Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization * History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders * History of serious recurrent or chronic infection * History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years * Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation * Currently active alcohol or drug abuse or history of alcohol or drug abuse

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lupus nephritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    33 sites in 10 countries. 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

  • Alder Hey Childrens Hospital

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • CH de Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • CHU de Toulouse - Hôpital des Enfants

    RECRUITING

    Toulouse, 31000, France

  • CREA Hospital Mexico Americano

    RECRUITING

    Guadalajara, Jalisco, 44620, Mexico

  • Centro de Pesquisa São Lucas

    RECRUITING

    Campinas, São Paulo, 13060-904, Brazil

  • Children's Hospital Colorado, Anchutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Chldren?s Hospital of Philadelphia

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Childrens Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Clinica El Golf

    ACTIVE_NOT_RECRUITING

    San Isidro, L27 Lima, Peru

  • Clinica Pediatrica II De Marchi

    RECRUITING

    Milan, Lombardy, 20122, Italy

  • Clinstile S.A de C.V.

    RECRUITING

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Cohen Children's Medical Center of New York

    RECRUITING

    Queens, New York, 11042, United States

  • Emory Children's Center

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Great Ormond Street Hospital for Children

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Groote Schuur Hospital

    WITHDRAWN

    Cape Town, 7925, South Africa

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hop Necker Enfants Malades

    RECRUITING

    Paris, 75743, France

  • Hospital Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Hospital Sant Joan De Deu

    RECRUITING

    Esplugas de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitário Onofre Lopes - UFRN

    RECRUITING

    Petrópolis, Rio Grande do Norte, 59012-300, Brazil

  • Hospital das Clinicas - FMUSP

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hôpital Robert Debré

    RECRUITING

    Paris, 75019, France

  • IRCCS G. Gaslini

    RECRUITING

    Genoa, Liguria, 16148, Italy

  • Indiana University Health University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Instituto de Ginecología y Reproducción

    ACTIVE_NOT_RECRUITING

    Lima, Peru

  • Loma Linda University health

    RECRUITING

    Loma Linda, California, 92354, United States

  • Louisiana State University

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Rome, Lazio, 00165, Italy

  • Panaroma Medical Center

    RECRUITING

    Panorama, 7500, South Africa

  • Red Cross War Memorial Children?s Hospital

    WITHDRAWN

    Cape Town, 7700, South Africa

  • Royal Hospital For Children

    WITHDRAWN

    Glasgow, G51 4TF, United Kingdom

  • Saint-Petersburg State

    WITHDRAWN

    St-peterburg, Sankt-Peterburg, 194100, Russia

  • Ser Servicos Especializados Em Reumatologia

    RECRUITING

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Szpital Specjalistyczny dla Dzieci i Doroslych

    WITHDRAWN

    Torun, 87-100, Poland

  • Texas Arthritis Center

    WITHDRAWN

    El Paso, Texas, 79902, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • UCSF Benioff Childrens Hospital

    RECRUITING

    San Francisco, California, 94158, United States

  • Universidade Federal de Sao Paulo - UNIFES

    ACTIVE_NOT_RECRUITING

    São Paulo, 04024-002, Brazil

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-294, Poland

More trials for these conditions

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