Clinical trial NCT01639339: Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Antibodies
Systemic Lupus Erythematosus
Autoimmune Disease
Glomerulonephritis
Belimumab
Lupus
Nephritis
Kidney Diseases
SLE
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2012-07-12
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104
timeFrame: Week 104
measure: Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
measure: Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)
timeFrame: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)
Secondary outcomes:
measure: Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104
timeFrame: Week 104
measure: Double-blind Period: Percentage of Participants With PERR at Week 52
timeFrame: Week 52
measure: Double-blind Period: Number of Participants With Time to Death or Renal Related Event
timeFrame: Up to Week 104
measure: Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104
timeFrame: Week 104
measure: Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs
timeFrame: Up to Week 104
measure: Double-blind Period: Number of Participants Reporting AESI
timeFrame: Up to Week 104
Other outcomes:
Locations:
city: La Palma
country: United States
facility: GSK Investigational Site
state: California
city: San Leandro
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Manhasset
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Bethlehem
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Onalaska
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Belo Horizonte, Minas Gerais
country: Brazil
facility: GSK Investigational Site
city: Goiania
country: Brazil
facility: GSK Investigational Site
city: Lajeado
country: Brazil
facility: GSK Investigational Site
city: Salvador
country: Brazil
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
city: Changsha
country: China
facility: GSK Investigational Site
state: Hunan
city: Nanchang
country: China
facility: GSK Investigational Site
state: Jiangxi
city: Shenyang
country: China
facility: GSK Investigational Site
state: Liaoning
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Beijing
country: China
facility: GSK Investigational Site
city: Chongqing
country: China
facility: GSK Investigational Site
city: Fuzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Nanning
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Xian
country: China
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Cean Cedex 09
country: France
facility: GSK Investigational Site
city: Créteil cedex
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Strasbourg Cedex
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: GSK Investigational Site
city: Vandoeuvre-Les-Nancy
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Goettingen
country: Germany
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Szeged
country: Hungary
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeju Special Self-Governing Prov.
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: GSK Investigational Site
state: Michoacán
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: México, D.F.
country: Mexico
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Leiden
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Davao City
country: Philippines
facility: GSK Investigational Site
city: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Lipa City, Batangas
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Orenburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Ufa
country: Russian Federation
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo/ Pontevedra
country: Spain
facility: GSK Investigational Site
city: Gueishan Township,Taoyuan County
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Muang
country: Thailand
facility: GSK Investigational Site
city: Rajathevee
country: Thailand
facility: GSK Investigational Site
city: Saimai
country: Thailand
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.
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.