Tacrolimus as secondary intervention vs. cyclosporine continuation in patients at risk for chronic renal allograft failure

Clin Transplant. 2005 Oct;19(5):573-80. doi: 10.1111/j.1399-0012.2005.00389.x.


Background: Chronic renal allograft failure (CRAF) is the leading cause of graft loss post-renal transplantation. This study evaluated the efficacy and safety of tacrolimus as secondary intervention in cyclosporine-treated kidney transplantation patients with impaired allograft function as indicated by elevated serum creatinine (SCr) levels.

Methods: Patients receiving cyclosporine-based immunosuppression who had an elevated SCr at least 3 months post-renal transplantation were enrolled. Treatment allocation was 2:1 to switch to tacrolimus or continue cyclosporine. This analysis was performed after 2 yr; patients will be followed for an additional 3 yr.

Results: There were 186 enrolled and evaluable patients. On baseline biopsy, 90% of patients had chronic allograft nephropathy. Baseline median SCr was 2.5 mg/dL in both treatment groups. For patients with graft function at month 24, SCr had decreased to 2.3 mg/dL in the tacrolimus-treated patients and increased to 2.6 mg/dL in the cyclosporine-treated patients (p = 0.01). Acute rejection occurred in 4.8% of tacrolimus-treated patients and 5.0% of cyclosporine-treated patients during follow-up. Two-year allograft survival was comparable between groups (tacrolimus 69%, cyclosporine 67%; p = 0.70). Tacrolimus-treated patients had significantly lower cholesterol and low-density lipoprotein levels and also had fewer new-onset infections. Cardiac conditions developed in significantly fewer tacrolimus-treated patients (5.6%) than cyclosporine-treated patients (24.3%; p = 0.004). Glucose levels and the incidences of new-onset diabetes and new-onset hyperglycemia did not differ between treatment groups.

Conclusions: Conversion from cyclosporine to tacrolimus results in improved renal function and lipid profiles, and significantly fewer cardiovascular events with no differences in the incidence of acute rejection or new-onset hyperglycemia.

Publication types

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

MeSH terms

  • Biopsy
  • Creatinine / blood
  • Cyclosporine / therapeutic use*
  • Delayed Graft Function / blood
  • Delayed Graft Function / drug therapy*
  • Delayed Graft Function / pathology
  • Female
  • Follow-Up Studies
  • Graft Rejection / blood
  • Graft Rejection / drug therapy*
  • Graft Rejection / pathology
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Failure, Chronic / drug therapy*
  • Kidney Failure, Chronic / etiology
  • Kidney Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Tacrolimus / therapeutic use*
  • Treatment Outcome


  • Immunosuppressive Agents
  • Cyclosporine
  • Creatinine
  • Tacrolimus