The ACCESS ITN034AI clinical trial for lupus nephritis achieved a milestone by completing enrollment of 137 participants, five months ahead of schedule. ACCESS is a randomized, placebo-controlled research study for participants 16 years of age or older who have been diagnosed with lupus and who have developed complications in their kidneys.
The goal of this trial is to determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective at improving lupus nephritis than standard cyclophosphamide therapy by itself.
Lupus nephritis is an inflammation of the kidney caused by systemic lupus erythematosus (SLE), a disease of the immune system. SLE affects an estimated 1.5 million Americans, 90% of whom are women. The majority of people with systemic lupus erythematosus will develop lupus nephritis - kidney disease caused by lupus - at some point in the course of their disease. Left untreated, lupus nephritis can be so damaging that dialysis or a kidney transplant may be needed.
Randomization of the participants began November 2009 and is being conducted at 24 clinical research centers across the U.S. and Mexico. Participants will remain in the study over a 2-year period. ACCESS study is under the direction of co-protocol chairs, Dr. Betty Diamond, from the Feinstein Institute, and Dr. David Wofsy, the George A. Zimmermann Distinguished Professor of Rheumatology at University of California, San Francisco.