Low-target tacrolimus in de novo standard risk renal transplant recipients: A single-centre experience

Nephrology (Carlton). 2016 Oct;21(10):821-7. doi: 10.1111/nep.12738.

Abstract

Aim: Optimal tacrolimus exposure in transplant recipients is not well established. The results from the Symphony study indicated that low-target tacrolimus (trough concentrations 3-7 µg/L) in de novo standard risk renal transplant recipients should be appropriate. The aim of this study was to evaluate real-life outcomes when applying a similar strategy in a clinical setting.

Methods: A single-centre analysis was conducted in standard risk renal transplant recipients receiving low-target tacrolimus, mycophenolate mofetil, glucocorticoids and basiliximab induction. One-year estimated glomerular filtration rate (eGFR, Cockcroft-Gault), one-year biopsy-proven acute rejection rate and graft- and patient survival up to 3 years post-transplant were compared with the outcomes in the Symphony study.

Results: From 1 January 2009 to 31 March 2013, we included 406 patients. One year after transplantation, the mean ± SD eGFR was 76.8 ± 28.3 mL/min (Symphony: 65.4 ± 27.0 mL/min, P < 0.001). Biopsy-proven acute rejections were seen in 14.5% of the patients (Symphony: 12.3%, P = 0.35). Kaplan-Meier estimates [95% confidence interval] of three-year death-censored graft- and patient survival were 96.6% [94.2-99.0%] (Symphony: 93%) and 95.0% [92.6-97.3%] (Symphony: 95%), respectively.

Conclusion: Low-target tacrolimus-based immunosuppression is safe and effective also in a standard clinical setting in de novo standard risk renal transplant recipients.

Keywords: calcineurin inhibitors; immunosuppression; kidney transplantation; symphony trial; tacrolimus.

MeSH terms

  • Adult
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Basiliximab
  • Biopsy
  • Dose-Response Relationship, Drug
  • Drug Monitoring / methods
  • Female
  • Glomerular Filtration Rate / drug effects
  • Glucocorticoids / administration & dosage
  • Graft Rejection* / epidemiology
  • Graft Rejection* / pathology
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Kidney Failure, Chronic* / diagnosis
  • Kidney Failure, Chronic* / epidemiology
  • Kidney Failure, Chronic* / surgery
  • Kidney Transplantation* / methods
  • Kidney Transplantation* / statistics & numerical data
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / adverse effects
  • Norway / epidemiology
  • Outcome and Process Assessment, Health Care
  • Recombinant Fusion Proteins / administration & dosage
  • Recombinant Fusion Proteins / adverse effects
  • Retrospective Studies
  • Risk Adjustment
  • Survival Analysis
  • Tacrolimus* / administration & dosage
  • Tacrolimus* / adverse effects

Substances

  • Antibodies, Monoclonal
  • Glucocorticoids
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Basiliximab
  • Mycophenolic Acid
  • Tacrolimus