Lupus nephritis (LN) affects approximately 40% of people with systemic lupus erythematosus (SLE). It is one of the most serious complications of the condition, and yet limited treatment options exist. Developing a new effective treatment option is a high medical priority, which is why the Clinical Translational Unit at Tulane University School of Medicine is conducting the REGENCY study.
The clinical study will evaluate the safety and effectiveness of the drug obinutuzumab in combination with current standard treatment. Obinutuzumab is currently approved for the treatment of certain leukemias and lymphomas, and is now being studied in other conditions such as LN.
The CTU hopes to enroll participants who are between the ages of 18 and 75 and have been diagnosed with LN. Eligible participants will either receive infusions of Obinutuzumab, a placebo, or a combination of the two over the course of 18 months. Participants will be monitored for up to 5 years following the last infusion depending on how they respond to the treatments.
LN is an autoimmune disease that causes B-cells to overreact and attack healthy cells in the kidney. A previous study found that obinutuzumab improved kidney function in patients with LN, and the CTU hopes to validate the results in a larger patient population.
For more information about the study and how to enroll, contact the Amanda Bard at (504) 988-9124 or Michelle Schmidt at (504) 988-9101.