Tacrolimus for induction therapy of diffuse proliferative lupus nephritis: an open-labeled pilot study

Kidney Int. 2005 Aug;68(2):813-7. doi: 10.1111/j.1523-1755.2005.00461.x.


Background: Tacrolimus is a relatively new calcineurin inhibitor that has been increasingly used in transplant medicine. The objective of the current work is to report our preliminary experience with tacrolimus in the treatment of diffuse proliferative glomerulonephritis in systemic lupus erythematosus (SLE).

Methods: Nine consecutive patients who fulfilled the American College of Rheumatology criteria for SLE and with biopsy-proven diffuse proliferative glomerulonephritis were recruited for an open-labeled trial with prednisolone and oral tacrolimus (0.1 mg/kg/day for 2 months, followed by 0.06 mg/kg/day). Prospective data on renal response and serologic lupus activity were collected. The efficacy and safety of this regimen was reported.

Results: Baseline characteristics of the patients were: mean age 33.3 +/- 12 years, women to men ratio 2:1, serum creatinine 94.2 +/- 46 micromol/L, daily proteinuria 4.56 +/- 2.4 g, seven (78%) patients were nephrotic, three (33%) were hypertensive, and four (44%) had elevated serum creatinine at the time of renal biopsy. At 6 months of therapy, complete and partial renal response was achieved in six (67%) and two (22%) patients, respectively. Significant improvement in proteinuria, hemoglobin, serum albumin, and C3 levels was observed in comparison with baseline values, starting at the second month. Tacrolimus was generally well tolerated, except for two patients who developed transient hyperglycemia. Infective complications, amenorrhea, hypertrichosis, gingivitis, new-onset hypertension, and significant increase in serum creatinine were not reported.

Conclusion: Tacrolimus is an effective option for induction treatment of SLE-diffuse proliferative glomerulonephritis. Further trials are necessary to determine the optimal dosage and duration of therapy, and its efficacy in comparison to standard regimens.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Lupus Nephritis / drug therapy*
  • Lupus Nephritis / pathology
  • Male
  • Middle Aged
  • Pilot Projects
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prospective Studies
  • Severity of Illness Index
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects


  • Glucocorticoids
  • Immunosuppressive Agents
  • Prednisolone
  • Tacrolimus