Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Official title: A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2021-06-25
Completion Date
2027-12-21
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (50)
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States
University of Colorado in Denver-Anschutz Medical Campus
Aurora, Colorado, United States
Accel Research Sites; Mid-Florida Kidney and Hypertension Care
Altamonte Springs, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Nephrotex Research Group
Dallas, Texas, United States
Organizacion Medica de Investigacion
Buenos Aires, Argentina
CINME
Buenos Aires, Argentina
Hospital Britanico Buenos Aires
Buenos Aires, Argentina
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Zhejiang Provincial People?s Hospital
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
The 1st Affiliated hospital of Fujian Medical University
Fuzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Huashan Hospital, Fudan University
Shanghai, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, China
General Hospital of Ningxia Medical University
Yinchuan, China
Hopital Henri Mondor
Créteil, France
Hopital Tenon
Paris, France
Hopital Rangueil
Toulouse, France
Sheba MC
Ramat Gan, Israel
Policlinico di Bari
Bari, Apulia, Italy
A.O. U. Federico II
Naples, Campania, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy
ASST Monza - Ospedale San Gerardo
Monza, Lombardy, Italy
Ospedale San Giovanni Bosco
Turin, Piedmont, Italy
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
?ód?, Poland
Uniwersytecki Szpital Kliniczny im WAM CSW
?ód?, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bia?ystok, Poland
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy
Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, Poland
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Moscow Oblast, Russia
Rostov State Medical Uni
Rostov-on-Don, Rostov Oblast, Russia
German clinic
Saint Petersburg, Sankt-Peterburg, Russia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hacettepe Uni School of Medicine
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Ege Uni School of Medicine
Izmir, Turkey (Türkiye)