A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis
A study for subjects with Lupus nephritis using an oral study drug MLN9708
Sponsor: Takeda
Enrolling: Male and Female Patients
Study Length: 168 Days
Clinic Visits: 19
IRB Number: AAAN9210
U.S. Govt. ID: NCT02176486
Contact: Anca Askanase MD MPH: 212-305-0856 / ada20@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate the safety and tolerability of an experimental investigational drug called ixazomib citrate (MLN9708) in patient with Lupus Nephritis. Lupus nephritis is a condition when the kidney is affected in the autoimmune disease known as systemic lupus erythematosus (SLE). SLE is a disease in which the immune system (the body system that fights infection) attacks your own cells and tissues, causing inflammation and candamage organs in the body. Lupus nephritis is a serious manifestation of SLE. In addition, this study will compare ixazomib citrate with a placebo to see if taking ixazomib citrate is better than taking a placebo. The placebo is a capsule that looks like a drug but has no drug in it.
This study is closed
Investigator
Anca Askanase, MD, MPH
Do You Qualify?
Do you have a diagnosis of lupus erythematosus (SLE)? Yes No
Do you have a definite diagnosis of lupus nephritis (LN)? Yes No
Should you qualify, would you agree to use two effective methods of contraception, at the same time, throughout the study? Yes No
Are you pregnant, lactating, or intend to become pregnancy before or during the study? Yes No
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Place Holder




For more information, please contact:
Anca Askanase MD MPH
ada20@cumc.columbia.edu
212-305-0856