Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)
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ClinicalTrials.gov Identifier: NCT01639339 |
Recruitment Status :
Completed
First Posted : July 12, 2012
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
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Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | July 10, 2012 | ||||||||||||||||||
First Posted Date ICMJE | July 12, 2012 | ||||||||||||||||||
Results First Submitted Date ICMJE | June 17, 2020 | ||||||||||||||||||
Results First Posted Date ICMJE | July 7, 2020 | ||||||||||||||||||
Last Update Posted Date | July 7, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | July 12, 2012 | ||||||||||||||||||
Actual Primary Completion Date | July 25, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 [ Time Frame: Week 104 ] PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGFR) 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 of 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 in one of 2 sites excluded due to GCP compliance. Percentage of participants with PERR at Week 104 has been presented.
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Original Primary Outcome Measures ICMJE |
Number of participants with a renal response at Week 104 [ Time Frame: 104 weeks ] | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis | ||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||
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. | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Lupus Nephritis | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
448 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
464 | ||||||||||||||||||
Actual Study Completion Date ICMJE | March 12, 2020 | ||||||||||||||||||
Actual Primary Completion Date | July 25, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Argentina, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Korea, Republic of, Mexico, Netherlands, Philippines, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, United States | ||||||||||||||||||
Removed Location Countries | Czech Republic | ||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT01639339 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 114054 2011-004570-28 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) | ||||||||||||||||||
Study Sponsor ICMJE | Human Genome Sciences Inc., a GSK Company | ||||||||||||||||||
Collaborators ICMJE | GlaxoSmithKline | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||||||||||||||||
Verification Date | June 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |