A Randomized, Double-Blind, Placebo-Controlled, Phase II, Multi-Center Study for Treatment of Lupus Nephritis by Inhibition of Tumor Necrosis Factor-alpha Using Etanercept
Kidney problems associated with lupus nephritis range from asymptomatic protein in the urine
to rapidly progressive glomerulonephritis, leading to end-stage renal disease. The goal of
therapies is to control kidney manifestations in order to avoid kidney failure, the
occurrence of other medical problems and death.
The treatment of lupus nephritis remains problematic. Despite the use of currently
available therapies, patients experience disease relapse. Over time, patients develop
significant morbidity from the disease as well as from medications used for treatment.
Etanercept, a TNF inhibitor, is proposed as a potential treatment for lupus nephritis. TNF
increases the number of reactive B and T cells. TNF levels can be elevated in lupus.
Etanercept is believed to work by blocking inflammation, and it is hoped that it will lessen
the signs and symptoms of lupus-related kidney disease.
The purpose of this study is to evaluate the safety and tolerability of etanercept compared
to placebo in combination with standard therapy to treat individuals with mild or moderately
active lupus nephritis.
This study will last 1 year. Participants will be randomly assigned to receive either
etanercept or placebo in addition to their regular medications. Participants will
self-administer 50 mg etanercept or placebo injections once a week. They will continue
receiving their usual treatment with corticosteroids and either MMF, Mycophenolic Acid, or
AZA. Treatment with study medication will occur for 24 weeks.
There will be a screening visit followed by a randomization visit, where subjects will
receive and learn how to administer the study drug. Subjects will come to the clinic for 9
study visits. A physical exam and blood and urine collection will occur at most study
visits. Participants will also be asked to complete a questionnaire on their health at most
study visits. Subjects will be contacted by phone 5 times during the 24-week period to
assess for adverse events and worsening disease status.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study
Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period.   This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.
Maria Dall'Era, MD
Division of Rheumatology, University of California, San Francisco
United States: Food and Drug Administration
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Duke University Medical Center||Durham, North Carolina 27710|
|University of Colorado Health Sciences Center||Denver, Colorado 80262|
|University of Rochester||Rochester, New York 14642|
|University of California at San Francisco||San Francisco, California 94115|
|Feinstein Institute for Medical Research NS-L1J Health System||Manhasset, New York 11030|