Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis



Status:Active, not recruiting
Conditions:Lupus, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:July 12, 2012
End Date:February 5, 2020

Use our guide to learn which trials are right for you!

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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab
in adult patients with active lupus nephritis.

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.

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.
We found this trial at
34
sites
Allentown, Texas 75013
?
mi
from
Allentown, TX
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Phone: 877-379-3718
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18105
Phone: 877-379-3718
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Brooklyn, New York 11215
Phone: 877-379-3718
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Phone: 877-379-3718
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
Phone: 877-379-3718
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Ciudad Autonoma Buenos Aires, Buenos Aires
Phone: 877-379-3718
?
mi
from
Ciudad Autonoma Buenos Aires,
Click here to add this to my saved trials
Columbus, Ohio 43219
Phone: 877-379-3718
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Flushing, New York 11355
Phone: 877-379-3718
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Great Neck, New York 11023
Phone: 877-379-3718
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Kennewick, Washington 99336
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
La Palma, California 90623
Phone: 877-379-3718
?
mi
from
La Palma, CA
Click here to add this to my saved trials
Los Angeles, California 90025
Phone: 877-379-3718
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Manhasset, New York 11030
Phone: 877-379-3718
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Miami, Florida 33136
Phone: 877-379-3718
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mobile, Alabama 36617
Phone: 877-379-3718
?
mi
from
Mobile, AL
Click here to add this to my saved trials
New York, New York 10032
Phone: 877-379-3718
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Ocoee, Florida 34761
Phone: 877-379-3718
?
mi
from
Ocoee, FL
Click here to add this to my saved trials
Onalaska, Wisconsin 54650
Phone: 877-379-3718
?
mi
from
Onalaska, WI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Phone: 877-379-3718
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Raleigh, North Carolina 27614
Phone: 877-379-3718
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Leandro, California 94578
Phone: 877-379-3718
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Tempe, Arizona 85284
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Torrance, California 90502
Phone: 877-379-3718
?
mi
from
Torrance, CA
Click here to add this to my saved trials