Trial reportEuropean journal of clinical pharmacology2016
Population pharmacokinetics and pharmacogenetics of once daily tacrolimus formulation in stable liver transplant recipients.
Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Relevance-Based Score for MIPD Model Selection: Systematic Review and External Evaluation of popPK Tacrolimus Models in Adult Transplant Recipients.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Model-Informed Precision Dosing of Tacrolimus: A Systematic Review of Population Pharmacokinetic Models and a Benchmark Study of Software Tools.Clinical pharmacokinetics · 2024Pooled it
- Population Pharmacokinetic Models of Tacrolimus in Adult Transplant Recipients: A Systematic Review.Clinical pharmacokinetics · 2020Pooled it
- Toward a robust tool for pharmacokinetic-based personalization of treatment with tacrolimus in solid organ transplantation: A model-based meta-analysis approach.British journal of clinical pharmacology · 2019Pooled it
- Tacrolimus 4-hour monitoring in liver transplant patients is non-inferior to trough monitoring: The randomized controlled FK04 trial.Clinical transplantation · 2022Trial
- Autologous bone marrow-derived mesenchymal stromal cell therapy with early tacrolimus withdrawal: The randomized prospective, single-center, open-label TRITON study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021Trial
- Evaluation of the performance of a prior tacrolimus population pharmacokinetic kidney transplant model among adult allogeneic hematopoietic stem cell transplant patients.Clinical and translational science · 2021Trial
- Population pharmacokinetic model and Bayesian estimator for 2 tacrolimus formulations in adult liver transplant patients.British journal of clinical pharmacology · 2019Trial
- Differential Oral Absorption Pharmacokinetics of Tacrolimus in Simultaneous Kidney-Pancreas Transplant Compared to Kidney Transplant Recipients.Clinical pharmacokinetics · 2026Observational
- A Review of Population Pharmacokinetic Models and Dosing Algorithms Assessing the Influence of CYP3A5 Genotype and Other Clinical Covariates on Tacrolimus Pharmacokinetics.Clinical pharmacokinetics · 2026Review
- Precision Dosing of Tacrolimus in Liver Transplantation: Integrating Donor-Recipient CYP3A5 Pharmacogenomics and Drug Interactions.CPT: pharmacometrics & systems pharmacology · 2026Article
- Low Tacrolimus CClinical pharmacokinetics · 2026Article
- A Novel Laboratory-Developed Test Using Multiplex qPCR to Further Personalize Tacrolimus Dosing.International journal of molecular sciences · 2026Article
- Navigating liver transplantation after malabsorptive bariatric surgery: A new risk of rejection.World journal of transplantation · 2026Article
- Analytical Models to Optimize Tacrolimus Dosing in Solid Organ Transplantation: A Systematic Review.Pharmaceutics · 2026Review
- Population pharmacokinetic modeling of tacrolimus using real-world data for precision dosing in pediatric liver transplant recipients younger than 36 months during the immediate postoperative period.Frontiers in pharmacology · 2026Article
- Effect of CYP3A4 Methylation on Tacrolimus Pharmacokinetics.Therapeutic drug monitoring · 2025Article
- A Tacrolimus Population Pharmacokinetic Model for Adult Allogeneic Hematopoietic Cell Transplant Recipients Provides Clinical Opportunities for Precision Dosing.Clinical pharmacokinetics · 2025Article
- Tacrolimus population pharmacokinetic model-informed precision dosing in adult liver transplant patients.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Development and validation of individualized tacrolimus dosing software for Chinese pediatric liver transplantation patients: a population pharmacokinetic approach.European journal of clinical pharmacology · 2024Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe once daily formulation of tacrolimus is an important immunosuppressive drug. Interpatient variability in metabolism has been related to genetic variation in CYP3A4 and CYP3A5. However, in liver transplantation, both donor and recipient genotypes may affect pharmacokinetics. The primary objective of this study was to investigate the effect of CYP3A4*22 and CYP3A5*3 of both donor and recipient on once daily tacrolimus pharmacokinetics. The secondary objective was to develop a limited sampling model able to accurately predict exposure.
methodsStable liver transplant patients receiving once daily tacrolimus (N = 66) were included. Population pharmacokinetic analysis was performed with patients of whom DNA was available (N = 49), and demographic factors, CYP3A4*22 and CYP3A5*3, were tested as covariates. Moreover, a limited sampling model was developed using data of 66 patients.
resultsPharmacokinetics was best described by a two-compartment model with delayed absorption. CYP3A5*1 carrying recipients engrafted with a CYP3A5*1 carrying liver had an average 1.7-fold higher clearance compared to non-carriers. CYP3A5*1 carrying recipients engrafted with a CYP3A5*1 non-carrying liver or vice versa showed an average 1.3-fold higher clearance compared with non-carriers. CYP3A4*22 was not significantly associated with once daily tacrolimus pharmacokinetics. Using 0, 2, and 3 h postdose as limited sampling model resulted in significantly improved prediction of tacrolimus exposure compared with trough concentration.
conclusionsBoth donor and recipient CYP3A5 genotype significantly influences tacrolimus once daily pharmacokinetics. In contrast, CYP3A4*22 appears not suitable as biomarker. The developed limited sampling model can be used to accurately estimate tacrolimus once daily exposure.
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