A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT ID: NCT04221477
Last Updated: 2025-11-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
271 participants
INTERVENTIONAL
2020-08-10
2031-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Obinutuzumab
Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit.
Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80.
Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.
After study unblinding, participants may be eligible for further open-label obinutuzumab treatment.
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Placebo
Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone.
Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80.
Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.
After study unblinding, participants may be eligible for further open-label obinutuzumab treatment.
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Placebo
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Interventions
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Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Placebo
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
Wallace Rheumatic Study Center
Beverly Hills, California, United States
Kaiser Permanente - Fontana
Fontana, California, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Univ Colorado Health Sci Ctr
Aurora, Colorado, United States
Yale Medical Group
New Haven, Connecticut, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Georgia Nephrology
Lawrenceville, Georgia, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
AD-CARE, University of Rochester Medical Center
Rochester, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
University of Texas Southwestern
Dallas, Texas, United States
Southwest Rheumatology
Mesquite, Texas, United States
University of Utah Health Science center
Salt Lake City, Utah, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
DOM Centro de Reumatología
Buenos Aires, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil
Instituto Pro-Renal
Curitiba, Paraná, Brazil
Hospital das Clinicas - FMUSP Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
Santo André, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Clinica De La Costa
Barranquilla, , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Hopital Henri Mondor
Créteil, , France
Hopital Claude Huriez
Lille, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
Hopital Rangueil
Toulouse, , France
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
Berlin, , Germany
Städtisches Klinik Dresden-Friedrichstadt
Dresden, , Germany
Universitätsklinikum "Carl Gustav Carus"
Dresden, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitaetsmedizin Johannes Gutenberg
Mainz, , Germany
Universitätskrankenhaus Tübingen
Tübingen, , Germany
Meir Medical Center
Kfar Saba, , Israel
Rabin MC- Belinson campus
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Centre
Tel Aviv, , Israel
Policlinico di Bari
Bari, Apulia, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Centro de Investigación y Tratamiento Reumatológico S.C.
Mexico City, Mexico CITY (federal District), Mexico
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario
Monterrey, Nuevo León, Mexico
Instituto Peruano del Hueso y la Articulación
Lima, , Peru
Clínica San Juan Bautista CSJB
Lima, , Peru
Instituto del Cerebro y la Columna Vertebral SAC
Lima, , Peru
Instituto de Ginecología y Reproducción
Lima, , Peru
Hospital Nacional Cayetano Heredia
San Martín de Porres, , Peru
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Medyczne Centrum Hetmanska
Poznan, , Poland
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
Poznan, , Poland
Szpital Kliniczny Dzieciatka Jezus
Warsaw, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
Moscow, Moscow Oblast, Russia
Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov
Saint Petersburg, Sankt-Peterburg, Russia
?Kazan (Privolzhsky) Federal University?
Kazan', Tatarstan Republic, Russia
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, , Russia
Groote Schuur Hospital and University of Cape Town
Cape Town, , South Africa
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, , United Kingdom
Countries
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References
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Furie RA, Rovin BH, Garg JP, Santiago MB, Aroca-Martinez G, Zuta Santillan AE, Alvarez D, Navarro Sandoval C, Lila AM, Tumlin JA, Saxena A, Irazoque Palazuelos F, Raghu H, Yoo B, Hassan I, Martins E, Sehgal H, Kirchner P, Ross Terres J, Omachi TA, Schindler T, Pendergraft WF 3rd, Malvar A; REGENCY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025 Apr 17;392(15):1471-1483. doi: 10.1056/NEJMoa2410965. Epub 2025 Feb 7.
Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-004034-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503628-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
CA41705
Identifier Type: -
Identifier Source: org_study_id