Tacrolimus is effective for lupus nephritis patients with persistent proteinuria

Clin Exp Rheumatol. 2010 Jan-Feb;28(1):6-12.


Objectives: To evaluate the safety and potential efficacy of tacrolimus for the treatment of patients with lupus nephritis and persistent proteinuria.

Methods: A total of 23 Japanese patients with lupus nephritis (21 females/2 males) were enrolled in this study. Patients were administered tacrolimus at a dose of 2-3 mg once daily after the evening meal for 6 months. The dose of tacrolimus was unchanged throughout the study period. Concomitant prednisolone therapy was unchanged or gradually tapered, while other immunosuppressants were stopped at the start of tacrolimus treatment.

Results: Tacrolimus was well tolerated, and none of the patients developed adverse drug reactions that required discontinuation of the study. Daily urinary protein loss, the U-prot/U-creat ratio, and serum albumin were significantly improved after 4 months, 3 months, and 1 month of treatment with tacrolimus (p<0.05), respectively, and the improvement persisted until 6 months. The serum complement hemolytic activity (CH50), complement C3 level, and CRP level were also significantly improved after treatment with tacrolimus (p<0.05). Improvement of the U-prot/U-creat ratio was most prominent for patients who were in WHO class IV.

Conclusions: Tacrolimus is safe and effective as maintenance therapy for patients with lupus nephritis, at least for 6 months. A larger randomised, controlled trial over a longer period is needed to confirm these results.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • C-Reactive Protein / metabolism
  • Complement C3 / metabolism
  • Complement Hemolytic Activity Assay
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / administration & dosage
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Lupus Nephritis / drug therapy*
  • Male
  • Middle Aged
  • Prednisolone / administration & dosage
  • Proteinuria / drug therapy*
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Treatment Outcome
  • Young Adult


  • Complement C3
  • Glucocorticoids
  • Immunosuppressive Agents
  • C-Reactive Protein
  • Prednisolone
  • Tacrolimus