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OBJECTIVE To assess the long-term safety and effectiveness of tacrolimus for treating lupus nephritis (LN) in the real-world clinical setting. METHODS This is an ongoing, open-label, non-comparative, observational, post-marketing surveillance study conducted across 275 sites in Japan. Registered LN patients are being followed for 10 years. Here we report data relating to 5 years of tacrolimus maintenance therapy at the interim data cutoff in August 2016. RESULTS Of 1395 registered patients, 1355 received tacrolimus mainten