Evidence map›Paper›PMID 33230714›Full record

ArticleClinical pharmacokinetics2021

Clinical Pharmacokinetics and Bayesian Estimators for the Individual Dose Adjustment of a Generic Formulation of Tacrolimus in Adult Kidney Transplant Recipients.

Pierre Marquet, Alexandre Destère, Caroline Monchaud, Jean-Philippe Rérolle, Matthias Buchler, Hakim Mazouz, Isabelle Etienne, Antoine Thierry, Nicolas Picard, Jean-Baptiste Woillard and 1 more

Registry-linked trialAbstract read
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In one paragraph

Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03076151 (Interventional Multicentre Pharmacokinetic Study of Adoport®), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03076151 phase4completednot on this map

Interventional Multicentre Pharmacokinetic Study of Adoport® (Tacrolimus) in Patients With de Novo Kidney Transplantation

TypeinterventionalSponsorUniversity Hospital, LimogesRan2018 to 2019Enrolled30ConditionsTransplantation, Kidney, PharmacokineticArmsTacrolimus monohydrate (ADOPORT®)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Pierre MarquetDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France. pierre.marquet@unilim.fr.ORCID http://orcid.org/0000-0001-7698-0760
Alexandre DestèreDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France.
Caroline MonchaudDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France.
Jean-Philippe RérolleIPPRITT, Université de Limoges, INSERM, Limoges, France.
Matthias BuchlerDepartment of Nephrology and Clinical Immunology, University Hospital, Tours, France.
Hakim MazouzDepartment of Nephrology, Dialysis and Transplantation, University Hospital, Amiens, France.
Isabelle EtienneDepartment of Nephrology, University Hospital, Rouen, France.
Antoine ThierryDepartment of Nephrology, Jean Bernard Hospital, University Hospital, Poitiers, France.
Nicolas PicardDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France.
Jean-Baptiste WoillardDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France.
Jean DebordDepartment of Pharmacology, Toxicology and Pharmacovigilance, CHU Limoges, University Hospital of Limoges, CBRS, Limoges, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTacrolimus has a narrow therapeutic range and requires dose adjustment, usually based on the trough blood concentration but preferably on the area under the concentration-time curve over 12 h post-dose (AUC

methodsThirty patients were enrolled and 29 provided nine blood samples over 9 h at day 7 and months 1 and 3 post-transplant. Tacrolimus blood profiles measured with liquid chromatography-tandem mass spectrometry were modelled using one-compartment, double gamma absorption, linear elimination models developed in-house. Different limited sampling strategies of three time-points within 4 h post-dose were tested for the maximum a-posteriori Bayesian estimator of tacrolimus AUC

resultsThe concentration-time curves, AUC

conclusionsWe developed original pharmacokinetic models and accurate maximum a-posteriori Bayesian estimators to estimate patient exposure and adjust the dose of generic tacrolimus, and confirmed that the robust tools previously developed for the original formulation can be applied to this generic.

Indexed as

Kidney TransplantationTacrolimusAdultArea Under CurveBayes TheoremHumansImmunosuppressive AgentsModels, BiologicalImmunosuppressive AgentsTacrolimus

Identifiers

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Registered trials

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.