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NCT04221477Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
271 (actual)
First submitted
7 Jan 2020
Start date
10 Aug 2020
Primary completion date
15 Aug 2024
Lead sponsor
Hoffmann-La Roche
Diseases
Lupus (SLE)
NCT number
NCT04221477
EU CT number
2023-503628-22-00
EudraCT number
2019-004034-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 271
  • From 10 Aug 2020 to the primary completion date, 15 Aug 2024
  • 70 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Intolerance or contraindication to study therapies

Other illness

  • Severe renal impairment or the need for dialysis or renal transplantation
  • 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

Other

  • Pregnancy or breastfeeding
  • Other exclusion criteria may apply

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Organización Médica de Investigación
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Buenos AiresArgentinaUnknown status
DOM Centro de Reumatología
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Buenos AiresArgentinaUnknown status
Sanatorio Allende
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CórdobaArgentinaUnknown status
Instituto Pro-Renal
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CuritibaBrazilUnknown status
Hospital das Clinicas - FMUSP Ribeirao Preto
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Ribeirão PretoBrazilUnknown status
Ser Servicos Especializados Em Reumatologia
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SalvadorBrazilUnknown status
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
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Santo AndréBrazilUnknown status
Hospital das Clinicas FMUSP
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São PauloBrazilUnknown status
Clinica De La Costa
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BarranquillaColombiaUnknown status
Hospital Universitario San Ignacio
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BogotáColombiaUnknown status
Hospital Pablo Tobón Uribe
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MedellínColombiaUnknown status
Staedtisches Klinikum Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Rabin MC- Belinson campus
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Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Sourasky Medical Centre
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Tel AvivIsraelUnknown status
University Hospital Consorziale Policlinico
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BariItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Centro de Investigación y Tratamiento Reumatológico S.C
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Mexico CityMexicoUnknown status
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
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Mexico CityMexicoUnknown status
Hospital Universitario
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MonterreyMexicoUnknown status
Instituto Peruano del Hueso y la Articulación
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LimaPeruUnknown status
Instituto del Cerebro y la Columna Vertebral SAC
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LimaPeruUnknown status
Clínica San Juan Bautista CSJB
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LimaPeruUnknown status
Instituto de Ginecología y Reproducción
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LimaPeruUnknown status
Hospital Nacional Cayetano Heredia
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San Martín de PorresPeruUnknown status
Medyczne Centrum Hetmańska
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PoznanPolandActive, not recruiting
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandActive, not recruiting
Rheuma Medicus Zaklad Opieki Zdrowotnej
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WarszawaPolandActive, not recruiting
Szpital Kliniczny Dzieciatka Jezus
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WarszawaPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
?Kazan (Privolzhsky) Federal University?
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Kazan'RussiaUnknown status
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
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MoscowRussiaUnknown status
Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov
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Saint PetersburgRussiaUnknown status
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
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Saint PetersburgRussiaUnknown status
Univ Colorado Health Sci Ctr
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AuroraUnited StatesUnknown status
Wallace Rheumatic Study Center
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Beverly HillsUnited StatesUnknown status
University of Alabama at Birmingham Medical Center
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BirminghamUnited StatesUnknown status
The Ohio State University -Wexner Medical Center
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ColumbusUnited StatesUnknown status
University of Texas, Southwestern
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DallasUnited StatesUnknown status
Kaiser Permanente-Fontana
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FontanaUnited StatesUnknown status
Georgia Nephrology
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LawrencevilleUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
Southwest Rheumatology
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MesquiteUnited StatesUnknown status
University of Miami Miller School of Medicine
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MiamiUnited StatesUnknown status
Yale Medical Group
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New HavenUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
NYU Langone Medical Center
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New YorkUnited StatesUnknown status
Oklahoma Medical Research Foundation
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Oklahoma CityUnited StatesUnknown status
AD-CARE, University of Rochester Medical Center
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RochesterUnited StatesUnknown status
University of Utah Health Science center
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Salt Lake CityUnited StatesUnknown status
Kaiser Permanente San Francisco Medical Center
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San FranciscoUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status
Groote Schuur Hospital and University of Cape Town
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Cape TownSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.