- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629248
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy (MAJESTY)
March 21, 2024 updated by: Hoffmann-La Roche
A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: WA41937 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: mailto:global-roche-genentech-trials@gene.com
Study Locations
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Buenos Aires, Argentina, C1056ABJ
- CINME
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Buenos Aires, Argentina, C1280AEB
- Hospital Britanico Buenos Aires; Rheumatology Service
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San Nicolás, Argentina, C1015ABO
- Organizacion Medica de Investigacion
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BA
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Salvador, BA, Brazil, 40150-150
- Ser Servicos Especializados Em Reumatologia
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SP
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Sao Jose do Rio Preto, SP, Brazil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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Sao Paulo, SP, Brazil, 05403-000
- Hospital das Clinicas - FMUSP; Nefrologia
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Sao Paulo, SP, Brazil, 04038-002
- Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
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Beijing City, China, 100034
- Peking University First Hospital
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Beijing City, China, 100032
- Peking Union Medical College Hospital
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Chengdu, China, 610072
- Sichuan Provincial People's Hospital
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Chengdu City, China, 610047
- West China Hospital - Sichuan University
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Fuzhou City, China, 350005
- The 1st Affiliated hospital of Fujian Medical University
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Guangzhou, China, 510515
- Nanfang Hospital, Southern Medical University
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Hangzhou, China, 310014
- Zhejiang Provincial People?s Hospital
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Shanghai City, China, 200040
- Huashan Hospital, Fudan University
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Shanghai City, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Wuhan City, China, 430030
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
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Xi'an City, China, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Yinchuan, China, 750004
- General Hospital of Ningxia Medical University
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Creteil, France, 94010
- HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
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Paris, France, 75020
- Hopital Tenon; Service de Nephrologie et Dialyses
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Toulouse, France, 31059
- Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
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Ramat-Gan, Israel, 5262000
- Sheba MC; Nephrology
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Campania
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Napoli, Campania, Italy, 80131
- A.O. U. Federico II; U.O. di Nefrologia - Dipartimento di Sanità Pubblica
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Lombardia
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Brescia, Lombardia, Italy, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
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Monza, Lombardia, Italy, 20900
- ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
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Piemonte
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Torino, Piemonte, Italy, 10154
- Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi
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Puglia
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Bari, Puglia, Italy, 70124
- Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
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?ód?, Poland, 90-153
- Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego; Oddzial Nefrologii
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?ód?, Poland, 92-213
- Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
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Bia?ystok, Poland, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku; II Klinika Nefrologii
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Bydgoszcz, Poland, 85-094
- Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy; Klinika Nefrologii, Nadcisnienia Tetniczego
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Wroc?aw, Poland, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; Klinika Nefrologii
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Moskovskaja Oblast
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Moscow, Moskovskaja Oblast, Russian Federation, 119991
- First Moscow State Medical University n.a. I.M. Sechenov
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Rostov
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Rostov-na-donu, Rostov, Russian Federation, 344022
- Rostov State Medical Uni ; Hematology
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Sankt Petersburg
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Sankt-peterburg, Sankt Petersburg, Russian Federation, 196128
- German clinic
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Barcelona, Spain, 08036
- Hospital Clinic i Provincial; Servicio de Nefrologia
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
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Madrid, Spain, 28007
- Hospital General Universitaro Gregorio Marañon ;Servicio de Nefrologia
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre; Servicio de Nefrologia
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, Spain, 46017
- Hospital Universitario Dr. Peset; Servicio de Nefrologia
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge; Servicio de Nefrologia
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Ankara, Turkey, 06100
- Hacettepe Uni School of Medicine; Nephrology
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Antalya, Turkey, 07059
- Akdeniz University Medical Faculty; Internal Medicine, Nephrology
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Izmir, Turkey, 35100
- Ege Uni School of Medicine; Nephrology
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Dnipropetrovsk, Ukraine, 49005
- Regional Clinical Hospital n.a I.I. Mechnicov
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Kherson Governorate
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Ternopil, Kherson Governorate, Ukraine, 46002
- Ternopil University Hospital
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Arizona
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Mesa, Arizona, United States, 85206
- Aventiv Research Inc
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California
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San Francisco, California, United States, 94118
- Kaiser Permanente - San Francisco Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado in Denver-Anschutz Medical Campus
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Florida
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Altamonte Springs, Florida, United States, 32701
- Accel Research Sites; Mid-Florida Kidney and Hypertension Care
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital; Div of Nephrology & Hypertension
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic; Nephrology and Hypertension
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Texas
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Dallas, Texas, United States, 75231
- Nephrotex Research Group
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Utah
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Salt Lake City, Utah, United States, 84113
- University of Utah Health Science center; Department of Pediatrics for the University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
- Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
- eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
- Other inclusion criteria may apply
Exclusion Criteria:
- Participants with a secondary cause of MN
- Pregnancy or breastfeeding
- Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
- Severe renal impairment, including the need for dialysis or renal replacement therapy
- Type 1 or 2 diabetes mellitus
- Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to 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
- Major surgery requiring hospitalization within the 4 weeks prior to screening
- Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
- Intolerance or contraindication to study therapies
- Other exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Open Label Treatment: Obinutuzumab
Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA).
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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.
Other Names:
Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
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.
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.
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Active Comparator: Open Label Treatment: Tacrolimus
Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of Participants who Achieve a Complete Remission (CR) at Week 104
Time Frame: Week 104
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Week 104
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants who Achieve an Overall Remission at Week 104
Time Frame: Week 104
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Week 104
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Percentage of Participants who Achieve CR at Week 76
Time Frame: Week 76
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Week 76
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Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission
Time Frame: Up to 8 years
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Up to 8 years
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Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline
Time Frame: Up to 8 years
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Up to 8 years
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Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
Time Frame: Baseline to Week 104
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Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale.
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Baseline to Week 104
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Duration of CR
Time Frame: Up to 8 years
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Up to 8 years
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Change in anti-PLA2R Autoantibody Titer
Time Frame: Baseline to Week 52
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Baseline to Week 52
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Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
Time Frame: Baseline to Week 104
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Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale
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Baseline to Week 104
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Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to 8 years
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Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
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Up to 8 years
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Percentage of Participants with AEs of Special Interest (AESIs)
Time Frame: Up to 8 years
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AESIs are required to be reported by the investigator to the Sponsor immediately
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Up to 8 years
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Peripheral B-cell Counts at Specified Timepoints
Time Frame: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 156, 182, 208 and every 26 weeks thereafter
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Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 156, 182, 208 and every 26 weeks thereafter
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Serum Concentrations of Obinutuzumab at Specified Timepoints
Time Frame: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 143, 156, 169, 182, 195, 208, every 26 weeks thereafter
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Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 143, 156, 169, 182, 195, 208, every 26 weeks thereafter
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Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
Time Frame: Open Label: Baseline; Escape Treatment: Week 0
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Open Label: Baseline; Escape Treatment: Week 0
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Incidence of ADAs during the study
Time Frame: Weeks 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 130, 156, 182, 208 and every 26 weeks thereafter
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Weeks 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 130, 156, 182, 208 and every 26 weeks thereafter
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2021
Primary Completion (Estimated)
December 29, 2025
Study Completion (Estimated)
December 29, 2027
Study Registration Dates
First Submitted
October 27, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Glomerulonephritis, Membranous
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antipyretics
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Calcineurin Inhibitors
- Methylprednisolone
- Acetaminophen
- Diphenhydramine
- Promethazine
- Tacrolimus
- Obinutuzumab
Other Study ID Numbers
- WA41937
- 2020-003233-38 (EudraCT Number)
- 2023-506525-11-00 (Other Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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