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A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy (MAJESTY)

Primary Purpose

Primary Membranous Nephropathy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obinutuzumab
Tacrolimus
Methylprednisolone
Acetaminophen
Diphenhydramine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Membranous Nephropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aventiv Research IncRecruiting
  • AKDHC Medical Research Services, LLC
  • Keck School of Medicine - University of Southern CaliforniaRecruiting
  • Kaiser Permanente - San Francisco Medical CenterRecruiting
  • University of Colorado in Denver-Anschutz Medical CampusRecruiting
  • Accel Research Sites; Mid-Florida Kidney and Hypertension Care
  • Loyola University Med CenterRecruiting
  • University of IowaRecruiting
  • Henry Ford Hospital; Div of Nephrology & HypertensionRecruiting
  • Mayo Clinic; Nephrology and HypertensionRecruiting
  • North Shore University HospitalRecruiting
  • Columbia University Medical CenterRecruiting
  • Penn State Univ. Milton S. Hershey Medical CenterRecruiting
  • Nephrotex Research GroupRecruiting
  • Prolato Clinical Research CenterRecruiting
  • University of Utah Health Science center; Department of Pediatrics for the University of UtahRecruiting
  • Multicare Health System
  • CINME
  • Hospital Britanico Buenos Aires; Rheumatology ServiceRecruiting
  • Hospital Italiano de Buenos Aires; Rheumatology department
  • Organizacion Medica de InvestigacionRecruiting
  • Ser Servicos Especializados Em ReumatologiaRecruiting
  • Hospital de Base de Sao Jose do Rio Preto
  • Hospital do Rim e Hipertensão - Fundação Oswaldo RamosRecruiting
  • Hospital das Clinicas - FMUSP; Nefrologia
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • West China Hospital - Sichuan University
  • Sichuan Provincial People's Hospital
  • The 1st Affiliated hospital of Fujian Medical University
  • Nanfang Hospital, Southern Medical University
  • Zhejiang Provincial People?s Hospital
  • Chinese People's Liberation Army Eastern Theater General Hospital
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Huashan Hospital, Fudan University
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xian Jiao Tong University
  • General Hospital of Ningxia Medical University
  • Hopital La Cavale Blanche; NephrologieRecruiting
  • HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
  • Hopital Tenon; Service de Nephrologie et DialysesRecruiting
  • Hopital Bichat Claude Bernard; NephrologieRecruiting
  • Hopital Rangueil; Service de Nephrologie & D'Immunologie CliniqueRecruiting
  • Rambam Medical Center; Department of Nephrology and HypertensionRecruiting
  • Hadassah Medical Orgainastion; NephrologyRecruiting
  • Sheba MC; Nephrology
  • A.O. U. Federico II; U.O. di Nefrologia - Dipartimento di Sanità PubblicaRecruiting
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
  • ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
  • Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi
  • Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
  • Hospital Alberto Sabogal Sologuren
  • Clinica Internacional - Sede San Borja
  • Clinica Peruana Americana
  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego; Oddzial NefrologiiRecruiting
  • Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
  • Uniwersytecki Szpital Kliniczny w Bialymstoku; II Klinika Nefrologii
  • Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy; Klinika Nefrologii, Nadcisnienia TetniczegoRecruiting
  • SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii
  • Miedzyleski Szpital Specjalistyczny w Warszawie; ODDZIA? NEFROLOGICZNYRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; Klinika NefrologiiRecruiting
  • First Moscow State Medical University n.a. I.M. Sechenov
  • Rostov State Medical Uni ; Hematology
  • Autonomous non-commercial organization "Medical Research Center of Drug Therapy "Yuninova"
  • German clinic
  • Hospital Universitari de Bellvitge; Servicio de NefrologiaRecruiting
  • Hospital Universitari Vall d'Hebron; Servicio de NefrologiaRecruiting
  • Hospital Clinic i Provincial; Servicio de Nefrologia
  • Hospital General Universitaro Gregorio Marañon ;Servicio de NefrologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de NefrologiaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Universitario Dr. Peset; Servicio de NefrologiaRecruiting
  • Hacettepe Uni School of Medicine; Nephrology
  • Akdeniz University Medical Faculty; Internal Medicine, Nephrology
  • Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
  • Istanbul Florence Nightingale Hospital; Nephrology
  • Ege Uni School of Medicine; Nephrology
  • Ternopil University Hospital
  • Oleksandrivska Clinical Hospital
  • Regional Clinical Hospital n.a I.I. Mechnicov
  • Institute of Nephrology NAMS of Ukraine; Department of Nephrology, Dialysis and IT Support

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open Label Treatment: Obinutuzumab

Open Label Treatment: Tacrolimus

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Percentage of Participants who Achieve a Complete Remission (CR) at Week 104

Secondary Outcome Measures

Percentage of Participants who Achieve an Overall Remission at Week 104
Percentage of Participants who Achieve CR at Week 76
Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission
Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline
Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale.
Duration of CR
Change in anti-PLA2R Autoantibody Titer
Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale
Percentage of Participants with Adverse Events (AEs)
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Percentage of Participants with AEs of Special Interest (AESIs)
AESIs are required to be reported by the investigator to the Sponsor immediately
Peripheral B-cell Counts at Specified Timepoints
Serum Concentrations of Obinutuzumab at Specified Timepoints
Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
Incidence of ADAs during the study

Full Information

First Posted
October 27, 2020
Last Updated
October 12, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04629248
Brief Title
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
Acronym
MAJESTY
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
January 9, 2025 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Membranous Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label Treatment: Obinutuzumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Open Label Treatment: Tacrolimus
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve a Complete Remission (CR) at Week 104
Time Frame
Week 104
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve an Overall Remission at Week 104
Time Frame
Week 104
Title
Percentage of Participants who Achieve CR at Week 76
Time Frame
Week 76
Title
Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission
Time Frame
Up to 8 years
Title
Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline
Time Frame
Up to 8 years
Title
Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
Description
Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale.
Time Frame
Baseline to Week 104
Title
Duration of CR
Time Frame
Up to 8 years
Title
Change in anti-PLA2R Autoantibody Titer
Time Frame
Baseline to Week 52
Title
Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
Description
Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale
Time Frame
Baseline to Week 104
Title
Percentage of Participants with Adverse Events (AEs)
Description
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time Frame
Up to 8 years
Title
Percentage of Participants with AEs of Special Interest (AESIs)
Description
AESIs are required to be reported by the investigator to the Sponsor immediately
Time Frame
Up to 8 years
Title
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
Title
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
Title
Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
Time Frame
Open Label: Baseline; Escape Treatment: Week 0
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WA41937 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
mailto:global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Aventiv Research Inc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Name
AKDHC Medical Research Services, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Withdrawn
Facility Name
Keck School of Medicine - University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente - San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado in Denver-Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites; Mid-Florida Kidney and Hypertension Care
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Loyola University Med Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital; Div of Nephrology & Hypertension
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic; Nephrology and Hypertension
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Univ. Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Nephrotex Research Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Health Science center; Department of Pediatrics for the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Name
Multicare Health System
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Withdrawn
Facility Name
CINME
City
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hospital Britanico Buenos Aires; Rheumatology Service
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires; Rheumatology department
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1199ABD
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Ser Servicos Especializados Em Reumatologia
City
Salvador
State/Province
BA
ZIP/Postal Code
40150-150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas - FMUSP; Nefrologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Individual Site Status
Completed
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Completed
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
Country
China
Individual Site Status
Completed
Facility Name
The 1st Affiliated hospital of Fujian Medical University
City
Fuzhou City
ZIP/Postal Code
350005
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Provincial People?s Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chinese People's Liberation Army Eastern Theater General Hospital
City
Nanjing
Country
China
Individual Site Status
Withdrawn
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Huashan Hospital, Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xian Jiao Tong University
City
Xi'an City
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hopital La Cavale Blanche; Nephrologie
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Tenon; Service de Nephrologie et Dialyses
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat Claude Bernard; Nephrologie
City
Paris
ZIP/Postal Code
75877
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Department of Nephrology and Hypertension
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Orgainastion; Nephrology
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba MC; Nephrology
City
Ramat-Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
A.O. U. Federico II; U.O. di Nefrologia - Dipartimento di Sanità Pubblica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10154
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Hospital Alberto Sabogal Sologuren
City
Callao
ZIP/Postal Code
Callao 02
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Clinica Internacional - Sede San Borja
City
San Borja
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Clinica Peruana Americana
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego; Oddzial Nefrologii
City
?ód?
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
City
?ód?
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku; II Klinika Nefrologii
City
Bia?ystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy; Klinika Nefrologii, Nadcisnienia Tetniczego
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie; ODDZIA? NEFROLOGICZNY
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; Klinika Nefrologii
City
Wroc?aw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
First Moscow State Medical University n.a. I.M. Sechenov
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Rostov State Medical Uni ; Hematology
City
Rostov-na-donu
State/Province
Rostov
ZIP/Postal Code
344022
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Autonomous non-commercial organization "Medical Research Center of Drug Therapy "Yuninova"
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
German clinic
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
196128
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari de Bellvitge; Servicio de Nefrologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial; Servicio de Nefrologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitaro Gregorio Marañon ;Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Dr. Peset; Servicio de Nefrologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni School of Medicine; Nephrology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Akdeniz University Medical Faculty; Internal Medicine, Nephrology
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Istanbul Florence Nightingale Hospital; Nephrology
City
Istanbul
ZIP/Postal Code
34403
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ege Uni School of Medicine; Nephrology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ternopil University Hospital
City
Ternopil
State/Province
Kherson Governorate
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Completed
Facility Name
Oleksandrivska Clinical Hospital
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01023
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Regional Clinical Hospital n.a I.I. Mechnicov
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Completed
Facility Name
Institute of Nephrology NAMS of Ukraine; Department of Nephrology, Dialysis and IT Support
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
33693991
Citation
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.
Results Reference
derived

Learn more about this trial

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

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