Tacrolimus as a steroid-sparing agent for adults with steroid-dependent minimal change nephrotic syndrome

Nephrol Dial Transplant. 2008 Jun;23(6):1919-25. doi: 10.1093/ndt/gfm637. Epub 2007 Oct 1.

Abstract

Background: Treatment of adults with steroid-dependent minimal change nephrotic syndrome (SD-MCNS) can be a significant challenge. Cyclophosphamide (CYC) and cyclosporin (CYA) are often effective steroid-sparing agents. Tacrolimus (TAC) may be another treatment option.

Methods: This open, prospective cohort study enrolled Chinese adults with SD-MCNS. At the start of the study, we administered TAC or intravenous CYC together with prednisone (0.5 mg/kg/day), the dose of which was tapered off throughout the study. The TAC cohort received oral TAC (target trough blood level of 4-8 ng/ml) for 24 weeks and the CYC cohort received intravenous CYC (750 mg/m(2) body surface) once every 4 weeks for 24 weeks.

Results: Twenty-six patients met the criteria for enrollment (14 patients in the CYC group and 12 patients in the TAC group). One patient from each group discontinued treatment because of a drug-related side effect. Complete remission (CR) after the 24-week therapeutic period was 76.9% (10/13) in the CYC group and 90.9% (10/11) in the TAC group. The mean time required for CR in the TAC group was significantly less than in the CYC group (P = 0.031). Eight of 13 (61.5%) patients in the CYC group and 8 of 11 (72.7%) patients in the TAC group successfully stopped steroids and changed their status from steroid dependence. Sixty percent (6/10) of the CYC patients and 50% (5/10) of the TAC patients who achieved CR maintained remission during the follow-up period of 23.0 +/- 10.1 months. Four (40%) CYC patients and five (50%) TAC patients experienced relapses, and two CYC patients experienced frequent relapses.

Conclusion: A 24-week course of TAC is a favorable steroid-sparing agent for treatment of Chinese adults with SD-MCNS. Therapy with TAC accompanied by a tapering dose of prednisolone appears to yield quicker remission than treatment with CYC together with prednisone.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Oral
  • Adult
  • Chi-Square Distribution
  • China
  • Creatinine / blood
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Infusions, Intravenous
  • Kidney Function Tests
  • Male
  • Middle Aged
  • Nephrosis, Lipoid / diagnosis
  • Nephrosis, Lipoid / drug therapy*
  • Probability
  • Proteinuria / physiopathology
  • Recurrence
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Treatment Outcome

Substances

  • Cyclophosphamide
  • Creatinine
  • Tacrolimus