Vol 18 (2025): Continuous Publishing
Research paper
Published online: 2025-03-31

open access

Page views 34
Article views/downloads 11
Get Citation

Connect on Social Media

Connect on Social Media

Retrospective analysis of tacrolimus concentrations and factors influencing their levels in adult kidney transplant recipients treated with Dailiport

Renal Disease and Transplantation Forum 2025;18.

Abstract

Introduction: One of the standard immunosuppressive drugs used after kidney transplantation is the calcineurin inhibitor — tacrolimus. Precise maintenance of appropriate blood concentrations of this drug is crucial to ensure clinical efficacy and to minimize adverse effects. However, data on achieving target concentration levels of Dailport — one of the newly registered generic prolonged-release tacrolimus formulations in Poland — are lacking, particularly regarding factors influencing this process in real-world clinical practice outside controlled clinical trials. Objective: The aim of this study is to provide these insights based on a retrospective analysis of kidney transplant patients from a single clinical center. Material and methods: A retrospective analysis of tacrolimus blood concentrations was conducted in 23 kidney transplant recipients. The observation period was 6 months. Results and conclusions: The analysis revealed typical fluctuations in tacrolimus blood concentrations, with a statistically significant trend toward stabilization at the target level after the first month of treatment (comparison: month 1 vs. months 2–3 and months 4–6). Due to the lack of identified additional factors influencing the achievement of target concentrations, further studies on larger patient cohorts, incorporating a broader range of potential influencing factors, are necessary.

Article available in PDF format

View PDF Download PDF file

References

  1. Abramyan S, Hanlon M. Kidney Transplantation. [Updated 2023 Jan 2]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. https://www.ncbi.nlm.nih.gov/books/NBK567755/.
  2. Poltransplant. Statystyki 2023. http://www.poltransplant.org.pl/statystyka_2023.html#gsc.tab=0.
  3. Bia M, Adey DB, Bloom RD, et al. Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009; 9 Suppl 3(2): S1–S155.
  4. Bentata Y. Tacrolimus: 20 years of use in adult kidney transplantation. What we should know about its nephrotoxicity. Artif Organs. 2020; 44(2): 140–152.
  5. Charakterystyka Produktu Leczniczego – Dailiport. Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych. https://leki.urpl.gov.pl/files/Dailiport.pdf.
  6. Hedeker D. A mixed-effects multinomial logistic regression model. Stat Med. 2003; 22(9): 1433–1446.
  7. R Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing; 2023. https://www.R-project.org/.
  8. Bürkner PC. brms: An R Package for Bayesian Multilevel Models Using Stan. Journal of Statistical Software. 2017; 80(1).
  9. Marquet P, Bedu A, Monchaud C, et al. Pharmacokinetic Therapeutic Drug Monitoring of Advagraf in More Than 500 Adult Renal Transplant Patients, Using an Expert System Online. Ther Drug Monit. 2018; 40(3): 285–291.
  10. Staatz C, Taylor P, Tett S. Low tacrolimus concentrations and increased risk of early acute rejection in adult renal transplantation. Nephrol Dial Transplant. 2001; 16(9): 1905–1909.
  11. Bouamar R, Shuker N, Hesselink DA, et al. Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(†). Am J Transplant. 2013; 13(5): 1253–1261.