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Trial record 1 of 2 for:    benlysta | "Lupus Nephritis"
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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis (BLISS-LN)

This study is currently recruiting participants.
Verified July 2017 by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639339
First Posted: July 12, 2012
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
  Purpose
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

Condition Intervention Phase
Lupus Nephritis Biological: Placebo plus standard therapy Biological: Belimumab 10 mg/kg plus standard therapy Drug: Standard therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

Primary Outcome Measures:
  • Number of participants with a renal response at Week 104 [ Time Frame: 104 weeks ]

Secondary Outcome Measures:
  • Number of participants with a complete renal response at Week 104 [ Time Frame: 104 weeks ]
  • Number of participants with a renal response at Week 52 [ Time Frame: 52 weeks ]
  • Number of participants who experienced adverse events [ Time Frame: up to 136 weeks ]

Estimated Enrollment: 464
Study Start Date: July 12, 2012
Estimated Study Completion Date: February 7, 2020
Estimated Primary Completion Date: July 26, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus standard therapy
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.
Biological: Placebo plus standard therapy
Placebo plus standard therapy
Drug: Standard therapy

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

Experimental: Belimumab 10 mg/kg plus standard therapy
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.
Biological: Belimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Other Name: BENLYSTA™
Drug: Standard therapy

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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639339


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 163 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01639339     History of Changes
Other Study ID Numbers: 114054
First Submitted: July 10, 2012
First Posted: July 12, 2012
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Antibodies
Systemic Lupus Erythematosus
Autoimmune Disease
Glomerulonephritis
Belimumab
Lupus
Nephritis
Kidney Diseases
SLE

Additional relevant MeSH terms:
Lupus Nephritis
Belimumab
Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs