Efficacy and safety of tacrolimus for lupus nephritis: a placebo-controlled double-blind multicenter study

Mod Rheumatol. 2009;19(6):606-15. doi: 10.1007/s10165-009-0218-5. Epub 2009 Aug 18.


We evaluated the efficacy and safety of tacrolimus in patients receiving glucocorticoid therapy for lupus nephritis. Patients with persistent nephritis were randomized to receive 28 weeks of double-blind treatment with tacrolimus (3 mg/day) or placebo. The primary endpoint was the change in the lupus nephritis disease activity index (LNDAI) calculated from scores for daily urinary protein excretion, urinary red cells, serum creatinine, anti-double-stranded DNA antibody, and serum complement. Statistical analysis was performed using the full analysis set. The LNDAI was decreased by 32.9 +/- 31.0% (mean +/- SD) in the tacrolimus group (n = 28) and was increased by 2.3 +/- 38.2% in the placebo group (n = 35) at final evaluation. There was significant improvement in the tacrolimus group. Daily urinary protein excretion showed a significant decrease in the tacrolimus group (p < 0.001). The complement (C3) level showed a significant increase in the tacrolimus group (p = 0.001). Treatment-related adverse events occurred in 92.9% of the tacrolimus group and 80.0% of the placebo group, but the difference was not significant. In patients on glucocorticoid therapy for lupus nephritis, addition of tacrolimus to basal therapy achieved significant improvement compared with placebo. Tacrolimus may therefore be a useful alternative treatment for lupus nephritis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Analysis of Variance
  • Complement C3 / metabolism
  • Creatinine / blood
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Lupus Nephritis / drug therapy*
  • Lupus Nephritis / metabolism
  • Male
  • Middle Aged
  • Patient Selection
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects*
  • Tacrolimus / blood
  • Treatment Outcome
  • Urinalysis


  • Complement C3
  • Immunosuppressive Agents
  • Creatinine
  • Tacrolimus