Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2017
A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study.
Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 1 of them a synthesis that pooled it.
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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.
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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.
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Who cites it
73 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Impact of MeltDose Technology Extended-Release Tacrolimus (LCPT) in Solid Organ Transplantation: A Systematic Review.Drug design, development and therapy · 2026Pooled it
- Tremors and Health-Related Quality of Life in Liver Transplant Recipients: Post-hoc Analysis of a Multicenter, Randomized, Controlled Trial Comparing a Life Cycle Pharma-Tacrolimus Regimen and Extended-Release Tacrolimus Regimen.Transplant international : official journal of the European Society for Organ Transplantation · 2025Trial
- A randomized crossover study comparing different tacrolimus formulations to reduce intrapatient variability in tacrolimus exposure in kidney transplant recipients.Clinical and translational science · 2022Trial
- Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus inTransplant international : official journal of the European Society for Organ Transplantation · 2022Trial
- Therapeutic Drug Monitoring Strategies for Envarsus in De Novo Kidney Transplant Patients Using Population Modelling and Simulations.Advances in therapy · 2021Trial
- Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules in De Novo Liver Transplant.Clinical pharmacology in drug development · 2019Trial
- Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study.Advances in therapy · 2019Trial
- Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.Journal of clinical pharmacology · 2018Trial
- Population Pharmacokinetics and Bayesian Estimators for Refined Dose Adjustment of a New Tacrolimus Formulation in Kidney and Liver Transplant Patients.Clinical pharmacokinetics · 2017Trial
- A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017Trial
- Low Tacrolimus CClinical pharmacokinetics · 2026Article
- Impact of Azole Antifungals on the Conversion Ratio of Immediate-release Tacrolimus to LCP-Tacrolimus Tablets in Non-kidney Solid Organ Transplant Recipients.Transplantation direct · 2026Article
- Tacrolimus intrapatient variability and latent virus reactivation after kidney transplantation: A retrospective study comparing prolonged-release and immediate-release tacrolimus formulations.The Journal of international medical research · 2026Observational
- Conversion to LCP Tacrolimus Mitigates Calcineurin-Induced Nephrotoxicity in Patients After Liver Transplantation.Clinical transplantation · 2026Article
- Dosing, Safety, and Tolerability of Extended-Release Tacrolimus in Pediatric and Young Adult Solid Organ Transplant Recipients.Pediatric transplantation · 2026Article
- Characterising Hand Tremor in Adult Kidney Transplant Recipients: Its Impact on Daily Activities and Relationship With Tacrolimus Administration and Exposure.Nephrology (Carlton, Vic.) · 2026Article
- Envarsus Versus Advagraf in De Novo Kidney Transplant Recipients: A Comparative Pharmacokinetic Study.Life (Basel, Switzerland) · 2026Article
- Integrating pharmacogenetic and clinical factors to predict the C0/D/W-based tacrolimus phenotype in kidney transplantation.Frontiers in pharmacology · 2026Article
- Comparative bioequivalence of 1 mg and 4 mg tacrolimus extended-release tablets: randomized, open label, fully replicate, crossover trials in healthy adult subjects.Frontiers in nephrology · 2026Article
- Impact of tacrolimus peak concentration on kidney graft outcomes.Transplant international : official journal of the European Society for Organ Transplantation · 2026Article
13 more citing papers are in PubMed but not listed here.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This two-sequence, three-period crossover study is the first pharmacokinetic (PK) study to compare all three innovator formulations of tacrolimus (twice-daily immediate-release tacrolimus capsules [IR-Tac]; once-daily extended-release tacrolimus capsules [ER-Tac]; novel once-daily tacrolimus tablets [LCPT]). Stable renal transplant patients were dosed with each drug for 7 days, and blood samples were obtained over 24 h. Thirty subjects were included in the PK analysis set. A conversion factor of 1:1:0.80 for IR-Tac:ER-Tac:LCPT was used; no dose adjustments were permitted during the study. The median (interquartile range) total daily dose was 6.0 (4.0-8.0) mg for IR-Tac and ER-Tac and 4.8 (3.3-6.3) for LCPT. Significantly higher exposure on a per milligram basis, lower intraday fluctuation and prolonged time (T
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