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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Standard therapy
Sponsored by
Human Genome Sciences Inc., a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Antibodies, Systemic Lupus Erythematosus, Autoimmune Disease, Glomerulonephritis, Belimumab, Lupus, Nephritis, Kidney Diseases, SLE

Eligibility Criteria

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

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
  • Biopsy confirmed active lupus nephritis.
  • Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
  • Autoantibody-positive.

Key Exclusion Criteria:

  • Pregnant or nursing.
  • On dialysis within the past year.
  • Treatment with belimumab within the past year .
  • Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
  • Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
  • Severe active central nervous system (CNS) lupus.
  • Required management of acute or chronic infections within the past 60 days.
  • Current drug or alcohol abuse or dependence.
  • Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • History of severe allergic reaction to contrast agents or biological medicines.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo plus standard therapy

Belimumab 10 mg/kg plus standard therapy

Arm Description

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Outcomes

Primary Outcome Measures

Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.

Secondary Outcome Measures

Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104
CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.
Double-blind Period: Percentage of Participants With PERR at Week 52
PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.
Double-blind Period: Number of Participants With Time to Death or Renal Related Event
Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.
Double-blind Period: Number of Participants Reporting AESI
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.

Full Information

First Posted
July 10, 2012
Last Updated
February 23, 2021
Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01639339
Brief Title
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Acronym
BLISS-LN
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2012 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc., a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Detailed Description
Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Antibodies, Systemic Lupus Erythematosus, Autoimmune Disease, Glomerulonephritis, Belimumab, Lupus, Nephritis, Kidney Diseases, SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo plus standard therapy
Arm Type
Placebo Comparator
Arm Description
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Arm Title
Belimumab 10 mg/kg plus standard therapy
Arm Type
Experimental
Arm Description
Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Intervention Type
Biological
Intervention Name(s)
Placebo plus standard therapy
Intervention Description
Placebo plus standard therapy
Intervention Type
Biological
Intervention Name(s)
Belimumab 10 mg/kg plus standard therapy
Other Intervention Name(s)
BENLYSTA™
Intervention Description
Belimumab 10 mg/kg plus standard therapy
Intervention Type
Drug
Intervention Name(s)
Standard therapy
Intervention Description
The standard therapies allowed in this study are: - High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR - High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy
Primary Outcome Measure Information:
Title
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
Description
PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
Time Frame
Week 104
Title
Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Time Frame
From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Title
Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)
Description
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.
Time Frame
From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Secondary Outcome Measure Information:
Title
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104
Description
CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.
Time Frame
Week 104
Title
Double-blind Period: Percentage of Participants With PERR at Week 52
Description
PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.
Time Frame
Week 52
Title
Double-blind Period: Number of Participants With Time to Death or Renal Related Event
Description
Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.
Time Frame
Up to Week 104
Title
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
Description
ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.
Time Frame
Week 104
Title
Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.
Time Frame
Up to Week 104
Title
Double-blind Period: Number of Participants Reporting AESI
Description
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.
Time Frame
Up to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. Biopsy confirmed active lupus nephritis. Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications. Autoantibody-positive. Key Exclusion Criteria: Pregnant or nursing. On dialysis within the past year. Treatment with belimumab within the past year . Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study. Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year. Severe active central nervous system (CNS) lupus. Required management of acute or chronic infections within the past 60 days. Current drug or alcohol abuse or dependence. Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. History of severe allergic reaction to contrast agents or biological medicines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
GSK Investigational Site
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
GSK Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
GSK Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
GSK Investigational Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GSK Investigational Site
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
Facility Name
GSK Investigational Site
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
GSK Investigational Site
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
CP 4000
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-320
Country
Brazil
Facility Name
GSK Investigational Site
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
GSK Investigational Site
City
Sao Jose do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
GSK Investigational Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
GSK Investigational Site
City
Belo Horizonte, Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
GSK Investigational Site
City
Goiania
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
GSK Investigational Site
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
GSK Investigational Site
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
GSK Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
GSK Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
GSK Investigational Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
GSK Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
GSK Investigational Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
GSK Investigational Site
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
GSK Investigational Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
GSK Investigational Site
City
Shenzhen
ZIP/Postal Code
518035
Country
China
Facility Name
GSK Investigational Site
City
Xian
Country
China
Facility Name
GSK Investigational Site
City
Bogota
Country
Colombia
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
GSK Investigational Site
City
Cean Cedex 09
ZIP/Postal Code
14033
Country
France
Facility Name
GSK Investigational Site
City
Créteil cedex
ZIP/Postal Code
94010
Country
France
Facility Name
GSK Investigational Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
GSK Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
GSK Investigational Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
GSK Investigational Site
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
GSK Investigational Site
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07740
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
GSK Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
GSK Investigational Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
GSK Investigational Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeju Special Self-Governing Prov.
ZIP/Postal Code
690-767
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju-si
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon-si, Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
GSK Investigational Site
City
Morelia
State/Province
Michoacán
ZIP/Postal Code
58260
Country
Mexico
Facility Name
GSK Investigational Site
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62170
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
7760
Country
Mexico
Facility Name
GSK Investigational Site
City
México, D.F.
ZIP/Postal Code
14080
Country
Mexico
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
GSK Investigational Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
GSK Investigational Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
GSK Investigational Site
City
Lipa City, Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo/ Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
GSK Investigational Site
City
Gueishan Township,Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
GSK Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
GSK Investigational Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
GSK Investigational Site
City
Rajathevee
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Saimai
ZIP/Postal Code
10220
Country
Thailand
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
36302567
Citation
Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.
Results Reference
derived
PubMed Identifier
34560137
Citation
Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.
Results Reference
derived
PubMed Identifier
32937045
Citation
Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

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