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A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

Primary Purpose

Lupus Nephritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obinutuzumab
MMF
Prednisone
Placebo
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 Lupus Nephritis

Eligibility Criteria

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

Key Inclusion Criteria:

  • Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
  • Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection
  • Other inclusion criteria may apply

Key Exclusion Criteria:

  • Pregnancy or breastfeeding
  • 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 patient participation
  • Known active infection of any kind or recent major episode of infection
  • Intolerance or contraindication to study therapies
  • Other exclusion criteria may apply

Sites / Locations

  • University of Alabama at Birmingham Medical Center
  • Wallace Rheumatic Study Center
  • Kaiser Permanente - Fontana
  • Stanford University Medical Center
  • Kaiser Permanente - San Francisco Medical Center
  • Univ Colorado Health Sci Ctr
  • Yale Medical Group; Rheumatology
  • University of Miami Miller School of Medicine
  • Mayo Clinic - Rochester
  • North Shore University Hospital
  • NYU Langone Medical Center; Seligman Center for Advanced Therapeutics
  • Columbia University Medical Center
  • AD-CARE, University of Rochester Medical Center
  • The Ohio State University Wexner Medical Center
  • Oklahoma Medical Research Foundation
  • Georgia Nephrology
  • University of Texas Southwestern
  • Southwest Rheumatology
  • University of Utah Health Science center; Internal Medicine for the University of Utah
  • DOM Centro de Reumatología
  • Sanatorio Allende
  • Organizacion Medica de Investigacion
  • Ser Servicos Especializados Em Reumatologia
  • Instituto Pro-Renal
  • Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
  • Hospital das Clinicas - FMUSP
  • Clinica De La Costa
  • Hospital Universitario San Ignacio
  • Hospital Pablo Tobon Uribe
  • HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
  • Hopital Claude Huriez; Internal Medicine
  • Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
  • Hopital Bichat Claude Bernard; Nephrologie
  • Hopital Universitaire; Nephrologie Clinique Medicale B
  • Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
  • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
  • Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik
  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
  • Universitätsklinikum Freiburg
  • Universitaetsmedizin Johannes Gutenberg; Rheumatologie
  • Universitätskrankenhaus Tübingen; Innere Medizin / Hämatologie und Internistische Onkologie
  • Meir Medical Center
  • Rabin MC- Belinson campus
  • Chaim Sheba Medical Center; Rheumatology
  • Sourasky Medical Centre
  • Ospedale Policlinico San Martino
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
  • Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
  • ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
  • Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
  • Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
  • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
  • Centro de Investigación y Tratamiento Reumatológico S.C.
  • Hospital Universitario; Dr. Jose Eleuterio Gonzalez
  • Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
  • Instituto del Cerebro y la Columna Vertebral SAC
  • Instituto de Ginecología y Reproducción
  • Hospital Nacional Cayetano Heredia; Rheumatology
  • SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Medyczne Centrum Hetmanska; Rheumatology
  • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
  • Szpital Kliniczny Dzieciatka Jezus; Klinika Med. Transplantacyjnej, Nefrologii i Chorob Wew
  • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
  • Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • ?Kazan (Privolzhsky) Federal University?; Academic Hospital
  • Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine
  • Chris Hani Baragwanath Hospital
  • Panaroma Medical Center; Clinical Trials Department
  • Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
  • Hospital Clinic i Provincial; Servicio de Nefrologia
  • Hospital Ramon y Cajal ; Servicio de Reumatologia
  • Hospital Universitario 12 de Octubre; Servicio de Reumatologia
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obinutuzumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Complete Renal Response (CRR)

Secondary Outcome Measures

Percentage of Participants who Achieve a Proteinuric Response
Percentage of Participants who Achieve Complete Renal Response (CRR) with Successful Prednisone Taper at Week 76
Percentage of Participants who Achieve an Overall Renal Response (ORR), Defined as Achievement of Either CRR or Partial Renal Response (PRR)
Percentage of Participants who Experience Death or Renal-related Events
Mean Change in Estimated Glomerular Filtration Rate (eGFR)
Change in Anti-dsDNA Titer
Change in Complement C3
Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time to Onset of CRR
Change in Fatigue (FACIT-F) Scale
Percentage of Participants who Achieve CRR with Serum Creatinine Criteria
Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Percentage of Participants with Adverse Events of Special Interest (Infusion Related Reactions, Neutropenia, Infections, Thrombocytopenia)
Maximum Serum Concentration of Obinutuzumab
Percentage of Participants with Anti-Drug Antibodies (ADAs) at Baseline and ADAs Post-Treatment
Change from Baseline in Total Peripheral B-Cell Count

Full Information

First Posted
January 7, 2020
Last Updated
September 25, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04221477
Brief Title
A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis
Acronym
REGENCY
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
August 16, 2024 (Anticipated)
Study Completion Date
February 28, 2029 (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, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obinutuzumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva, GA101, RO5072759
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MMF
Intervention Description
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Primary Outcome Measure Information:
Title
Percentage of Participants with Complete Renal Response (CRR)
Time Frame
At Week 76
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve a Proteinuric Response
Time Frame
At Week 76
Title
Percentage of Participants who Achieve Complete Renal Response (CRR) with Successful Prednisone Taper at Week 76
Time Frame
At Week 76
Title
Percentage of Participants who Achieve an Overall Renal Response (ORR), Defined as Achievement of Either CRR or Partial Renal Response (PRR)
Time Frame
At Week 50
Title
Percentage of Participants who Experience Death or Renal-related Events
Time Frame
From baseline to Week 76
Title
Mean Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame
From baseline to Week 76
Title
Change in Anti-dsDNA Titer
Time Frame
From baseline to Week 50
Title
Change in Complement C3
Time Frame
From baseline to Week 50
Title
Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time Frame
From baseline to Week 76
Title
Time to Onset of CRR
Time Frame
From baseline to Week 76
Title
Change in Fatigue (FACIT-F) Scale
Time Frame
From baseline to Week 76
Title
Percentage of Participants who Achieve CRR with Serum Creatinine Criteria
Time Frame
At Week 76
Title
Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time Frame
From baseline to Week 76
Title
Percentage of Participants with Adverse Events of Special Interest (Infusion Related Reactions, Neutropenia, Infections, Thrombocytopenia)
Time Frame
From baseline to Week 76
Title
Maximum Serum Concentration of Obinutuzumab
Time Frame
Baseline, Week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Title
Percentage of Participants with Anti-Drug Antibodies (ADAs) at Baseline and ADAs Post-Treatment
Time Frame
From baseline to Week 76
Title
Change from Baseline in Total Peripheral B-Cell Count
Time Frame
Baseline, Week 4, 12, 24, 50 and 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection Other inclusion criteria may apply Key Exclusion Criteria: Pregnancy or breastfeeding 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 patient participation Known active infection of any kind or recent major episode of infection Intolerance or contraindication to study therapies Other exclusion criteria may apply
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
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Kaiser Permanente - Fontana
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Permanente - San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Univ Colorado Health Sci Ctr
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Medical Group; Rheumatology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center; Seligman Center for Advanced Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AD-CARE, University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Georgia Nephrology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8897
Country
United States
Facility Name
Southwest Rheumatology
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
University of Utah Health Science center; Internal Medicine for the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
DOM Centro de Reumatología
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1111AAJ
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Ser Servicos Especializados Em Reumatologia
City
Salvador
State/Province
BA
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
Instituto Pro-Renal
City
Curitiba
State/Province
PR
ZIP/Postal Code
80440-020
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Clinica De La Costa
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Hospital Universitario San Ignacio
City
Bogota
ZIP/Postal Code
000472
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Claude Huriez; Internal Medicine
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Bichat Claude Bernard; Nephrologie
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Hopital Universitaire; Nephrologie Clinique Medicale B
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsmedizin Johannes Gutenberg; Rheumatologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätskrankenhaus Tübingen; Innere Medizin / Hämatologie und Internistische Onkologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Meir Medical Center
City
Kfar- Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin MC- Belinson campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center; Rheumatology
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Sourasky Medical Centre
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
Tlalpan 14000
Country
Mexico
Facility Name
Centro de Investigación y Tratamiento Reumatológico S.C.
City
Mexico, DF
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Hospital Universitario; Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
City
Lima
ZIP/Postal Code
15431
Country
Peru
Facility Name
Instituto del Cerebro y la Columna Vertebral SAC
City
Lima
ZIP/Postal Code
Lima 18
Country
Peru
Facility Name
Instituto de Ginecología y Reproducción
City
Lima
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia; Rheumatology
City
San Martin de Porres
ZIP/Postal Code
15102
Country
Peru
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
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Medyczne Centrum Hetmanska; Rheumatology
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Szpital Kliniczny Dzieciatka Jezus; Klinika Med. Transplantacyjnej, Nefrologii i Chorob Wew
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
?Kazan (Privolzhsky) Federal University?; Academic Hospital
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420043
Country
Russian Federation
Facility Name
Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Panaroma Medical Center; Clinical Trials Department
City
Panorama
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Nefrologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Ramon y Cajal ; Servicio de Reumatologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Reumatologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

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 To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

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