Trial reportEuropean journal of clinical pharmacology2013
Pharmaceutical and genetic determinants for interindividual differences of tacrolimus bioavailability in renal transplant recipients.
Trial report in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Pooled it
- Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis.European journal of clinical pharmacology · 2018Pooled it
- Significant association between CYP3A5 polymorphism and blood concentration of tacrolimus in patients with connective tissue diseases.Journal of human genetics · 2014Trial
- Physiologically based pharmacokinetic model combined with reverse dose method to study the nephrotoxic tolerance dose of tacrolimus.Archives of toxicology · 2023Article
- A systematic review and meta-analysis recite the efficacy of Tacrolimus treatment in renal transplant patients in association with genetic variants ofAmerican journal of clinical and experimental urology · 2023Review
- Association of CYP3A5 polymorphisms and parathyroid hormone with blood level of tacrolimus in patients with end-stage renal disease.Clinical and translational science · 2021Article
- Therapeutic drug monitoring of regorafenib and its metabolite M5 can predict treatment efficacy and the occurrence of skin toxicities.International journal of clinical oncology · 2020Observational
- Biomarkers and Pharmacogenomics in Kidney Transplantation.Molecular diagnosis & therapy · 2018Review
- Prediction of Tacrolimus Exposure by CYP3A5 Genotype and Exposure of Co-Administered Everolimus in Japanese Renal Transplant Recipients.International journal of molecular sciences · 2018Article
- Impact of the CYP3A5 genotype on the distributions of dose-adjusted trough concentrations and incidence of rejection in Japanese renal transplant recipients receiving different tacrolimus formulations.Clinical and experimental nephrology · 2017Article
- Once-daily prolonged-release tacrolimus formulations for kidney transplantation: what the nephrologist needs to know.Journal of nephrology · 2017Review
- Effects of CYP3A5 polymorphism on the pharmacokinetics of a once-daily modified-release tacrolimus formulation and acute kidney injury in hematopoietic stem cell transplantation.Cancer chemotherapy and pharmacology · 2016Article
- The role of CYP3A5 polymorphism and dose adjustments following conversion of twice-daily to once-daily tacrolimus in renal transplant recipients.Transplantation research · 2016Article
- Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients.Clinical pharmacokinetics · 2015Review
- Novel immunosuppressive agent caerulomycin A exerts its effect by depleting cellular iron content.British journal of pharmacology · 2015Article
- Capability of utilizing CYP3A5 polymorphisms to predict therapeutic dosage of tacrolimus at early stage post-renal transplantation.International journal of molecular sciences · 2015Article
- Review
- The role of pharmacogenetics in the disposition of and response to tacrolimus in solid organ transplantation.Clinical pharmacokinetics · 2014Review
- Update on the clinical utility of once-daily tacrolimus in the management of transplantation.Drug design, development and therapy · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe pharmacokinetics of orally administered immediate-release, twice-daily (BID) and modified-release, once-daily (QD) formulations of tacrolimus have high interindividual variability. We investigated factors affecting interindividual variability of tacrolimus bioavailability in renal transplant patients.
methodsNinety-seven Japanese renal transplant patients (47 patients on tacrolimus BID and 50 patients on tacrolimus QD) were enrolled in this study. The tacrolimus absolute bioavailability was calculated using the area under the concentration-time curve from 0 to 24 h (AUC0-24) after continuous intravenous infusion and oral formulations of tacrolimus in the same recipient.
resultsThe median (quartile 1-quartile 3) tacrolimus relative bioavailability for recipients with the CYP3A5*1 or CYP3A5*3/*3 alleles was significantly lower for the tacrolimus QD group [9.1 % (6.3-10.7 %) and 15.4 % (11.5-18.7 %), respectively] than for the tacrolimus BID group [12.6 % (9.9-14.2 %) and 19.3 % (16.5-24.8 %), respectively] (P = 0.004 and 0.028, respectively). Consequently, tacrolimus absolute bioavailability was lowest for recipients with the CYP3A5*1 allele taking tacrolimus QD. The CYP3A5 polymorphism had no impact on the dose-adjusted AUC0-24 of tacrolimus in patients on continuous intravenous infusion (P = 0.906).
conclusionThe larger interindividual variability of tacrolimus bioavailability for oral formulations appears to be due to the effects of the CYP3A5 polymorphism and the tacrolimus oral formulation. These factors should therefore be taken into account when determining individualized tacrolimus dosing.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.