142
Participants
Start Date
June 25, 2021
Primary Completion Date
December 25, 2025
Study Completion Date
December 23, 2027
Obinutuzumab
Open Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment.
Tacrolimus
Open Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment.
Methylprednisolone
Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
Acetaminophen
Premedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
Diphenhydramine
Premedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
Columbia University Medical Center, New York
Ospedale San Giovanni Bosco, Turin
ASST Monza - Ospedale San Gerardo, Monza
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili, Brescia
Hospital Universitario 12 de Octubre, Madrid
Hopital Rangueil, Toulouse
Accel Research Sites; Mid-Florida Kidney and Hypertension Care, Altamonte Springs
Ege Uni School of Medicine, Izmir
Hospital Universitario Virgen del Rocío, Seville
Henry Ford Hospital, Detroit
University of Iowa, Iowa City
Sheba MC, Ramat Gan
Mayo Clinic, Rochester
Policlinico di Bari, Bari
Hopital Tenon, Paris
Nephrotex Research Group, Dallas
University of Colorado in Denver-Anschutz Medical Campus, Aurora
A.O. U. Federico II, Napoli
Hopital Henri Mondor, Créteil
Kaiser Permanente - San Francisco Medical Center, San Francisco
Peking University First Hospital, Beijing
First Moscow State Medical University n.a. I.M. Sechenov, Moscow
German clinic, Saint Petersburg
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Huashan Hospital, Fudan University, Shanghai
Zhejiang Provincial People?s Hospital, Hangzhou
Rostov State Medical Uni, Rostov-on-Don
The 1st Affiliated hospital of Fujian Medical University, Fuzhou
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Nanfang Hospital, Southern Medical University, Guangzhou
Sichuan Provincial People's Hospital, Chengdu
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an
General Hospital of Ningxia Medical University, Yinchuan
Organizacion Medica de Investigacion, Buenos Aires
CINME, Buenos Aires
Hospital Britanico Buenos Aires, Buenos Aires
Ser Servicos Especializados Em Reumatologia, Salvador
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos, São Paulo
Hospital das Clinicas - FMUSP, São Paulo
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, ?ód?
Uniwersytecki Szpital Kliniczny im WAM CSW, ?ód?
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bia?ystok
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy, Bydgoszcz
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroc?aw
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clinic i Provincial, Barcelona
Hacettepe Uni School of Medicine, Ankara
Akdeniz University Medical Faculty, Antalya
Hoffmann-La Roche
INDUSTRY