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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
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Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled

R Bouamar1, N Shuker, D A Hesselink

  • 1Department of Hospital Pharmacy, Erasmus MC, Rotterdam, the Netherlands.

American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons
|March 14, 2013
PubMed

Insights

Therapeutic drug monitoring of tacrolimus (Tac) is common, but its effectiveness in preventing kidney transplant rejection is unclear. This study found no significant association between Tac concentrations and acute rejection, suggesting current targets may need reevaluation.

Area of Science:

  • Nephrology
  • Immunology
  • Pharmacology

Background:

  • Therapeutic drug monitoring (TDM) for tacrolimus (Tac) is standard practice in kidney transplantation.
  • The precise concentration-effect relationship for Tac, particularly concerning acute rejection, remains poorly defined.

Purpose of the Study:

  • To investigate the association between tacrolimus predose concentrations and biopsy-proven acute rejection (BPAR) in kidney transplant recipients.
  • To determine if current TDM targets for tacrolimus are associated with reduced BPAR incidence.

Main Methods:

  • Pooled data from three large clinical trials involving kidney transplant recipients.
  • Univariate and multivariate analyses were performed to assess the relationship between Tac predose concentrations and BPAR.
  • Tac concentrations were measured at five key time points post-transplantation (days 3, 10, 14, and months 1, 6).

Main Results:

  • The overall incidence of BPAR was 10.4% (136/1304 patients).
  • No significant correlation was found between tacrolimus predose concentrations and BPAR at any of the assessed time points.
  • Delayed graft function and induction therapy were independently associated with BPAR, but tacrolimus levels were not.

Conclusions:

  • Tacrolimus predose concentrations measured at five time points after kidney transplantation were not associated with the incidence of acute rejection.
  • This study could not establish optimal target concentrations for tacrolimus to prevent BPAR.
  • Factors other than tacrolimus levels, such as delayed graft function and induction therapy, appear more critical in predicting acute rejection.

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