Trial record 5 of 109 for:    Open Studies | "Nephritis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01639339
First received: July 10, 2012
Last updated: August 7, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Number of participants with a renal response at Week 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with a complete renal response at Week 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Number of participants with a renal response at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of participants who experienced adverse events [ Time Frame: up to 136 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 464
Study Start Date: July 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: February 2017 (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 within 2 weeks 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
  • Biopsy confirmed active lupus nephritis.
  • Autoantibody-positive.

Key Exclusion Criteria:

  • Pregnant or nursing.
  • On dialysis within the past year.
  • Prior treatment with belimumab.
  • Receipt of any induction therapy within the past 6 months.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639339

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

  Show 117 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01639339     History of Changes
Other Study ID Numbers: 114054, HGS1006-C1121, 2011-004570-28
Study First Received: July 10, 2012
Last Updated: August 7, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Brazil: National Health Surveillance Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Korea: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Hungary: National Institute of Pharmacy
Thailand: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Taiwan: Department of Health
Philippines: Bureau of Food and Drugs
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Mexico: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by GlaxoSmithKline:
Antibodies
Systemic Lupus Erythematosus
Autoimmune Disease
Glomerulonephritis
Belimumab
Lupus
Nephritis
Kidney Diseases
SLE

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

ClinicalTrials.gov processed this record on August 19, 2014