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 drug shows promise for lupus kidney patients in major trial

NCT ID NCT04221477

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 2 times

Summary

This study tests a drug called obinutuzumab for people with lupus nephritis, a kidney disease caused by lupus. About 271 participants receive either the drug or a placebo, added to their usual treatment. The goal is to see if the drug helps achieve complete kidney response, meaning less protein in urine and stable kidney function.

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

271 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Mar 2031

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

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.

Key Inclusion Criteria: * Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease * Urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection * Other inclusion criteria may apply Key Exclusion Criteria: * Pregnancy or breastfeeding * Severe renal impairment or the need for dialysis or renal transplantation * Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening * Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation * Known active infection of any kind or recent major episode of infection * Intolerance or contraindication to study therapies * Other exclusion criteria may apply

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

Contacts and locations

Locations

  • ?Kazan (Privolzhsky) Federal University?

    Kazan', Tatarstan Republic, 420043, Russia

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy, 25123, Italy

  • AD-CARE, University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50141, Italy

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128, Italy

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

    Santo André, São Paulo, 09190-510, Brazil

  • Centro de Investigación y Tratamiento Reumatológico S.C.

    Mexico City, Mexico CITY (federal District), 11850, Mexico

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

    Berlin, 10117, Germany

  • Clinica De La Costa

    Barranquilla, Colombia

  • Clínica San Juan Bautista CSJB

    Lima, 15431, Peru

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAJ, Argentina

  • Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov

    Saint Petersburg, Sankt-Peterburg, 197341, Russia

  • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

    Moscow, Moscow Oblast, 115522, Russia

  • Georgia Nephrology

    Lawrenceville, Georgia, 30046, United States

  • Groote Schuur Hospital and University of Cape Town

    Cape Town, 7925, South Africa

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651, France

  • Hopital Bichat Claude Bernard

    Paris, 75877, France

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hospital Clinic i Provincial

    Barcelona, 08036, Spain

  • Hospital Nacional Cayetano Heredia

    San Martín de Porres, 15102, Peru

  • Hospital Pablo Tobon Uribe

    Medellín, 050034, Colombia

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario San Ignacio

    Bogotá, 000472, Colombia

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital das Clinicas - FMUSP Ribeirao Preto

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

    Mexico City, Mexico CITY (federal District), Tlalpan 14000, Mexico

  • Instituto Peruano del Hueso y la Articulación

    Lima, 15046, Peru

  • Instituto Pro-Renal

    Curitiba, Paraná, 80440-020, Brazil

  • Instituto de Ginecología y Reproducción

    Lima, Peru

  • Instituto del Cerebro y la Columna Vertebral SAC

    Lima, Lima 18, Peru

  • Kaiser Permanente - Fontana

    Fontana, California, 92335, United States

  • Kaiser Permanente - San Francisco Medical Center

    San Francisco, California, 94118, United States

  • Medyczne Centrum Hetmanska

    Poznan, 60-218, Poland

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

    Warsaw, 02-637, Poland

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104, United States

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO, Argentina

  • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM

    Poznan, 61-545, Poland

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132, Italy

  • Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Rabin MC- Belinson campus

    Petah Tikva, 49100, Israel

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118, Poland

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, 197022, Russia

  • Sanatorio Allende

    Córdoba, X5000JHQ, Argentina

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Sourasky Medical Centre

    Tel Aviv, 64239, Israel

  • Southwest Rheumatology

    Mesquite, Texas, 75150, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Städtisches Klinik Dresden-Friedrichstadt

    Dresden, 01067, Germany

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-006, Poland

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212, United States

  • Univ Colorado Health Sci Ctr

    Aurora, Colorado, 80045, United States

  • Universitaetsmedizin Johannes Gutenberg

    Mainz, 55131, Germany

  • University of Alabama at Birmingham Medical Center

    Birmingham, Alabama, 35233, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390-8897, United States

  • University of Utah Health Science center

    Salt Lake City, Utah, 84113, United States

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätskrankenhaus Tübingen

    Tübingen, 72076, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-556, Poland

  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954, Poland

  • Wallace Rheumatic Study Center

    Beverly Hills, California, 90211, United States

  • Yale Medical Group

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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