Evidence map›Paper›PMID 38444519›Full record

ArticleFrontiers in nephrology2024

A multi-center interventional study to assess pharmacokinetics, effectiveness, and tolerability of prolonged-release tacrolimus after pediatric kidney transplantation: study protocol for a prospective, open-label, randomized, two-phase, two-sequence, single dose, crossover, phase III b trial.

Sinem Karaterzi, Burkhard Tönshoff, Thurid Ahlenstiel-Grunow, Maral Baghai, Bodo Beck, Anja Büscher, Lisa Eifler, Thomas Giese, Susanne Lezius, Carsten Müller and 4 more

Registry-linked trialOpen access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06057545 (A Multi-center Interventional Study to Assess Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 41% of its field
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.

NCT06057545 phase3unknown statusnot on this map

A Multi-center Interventional Study to Assess Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation

TypeinterventionalSponsorUniversity Hospital, EssenRan2023 to 2025Enrolled30ConditionsPediatric Kidney DiseaseArmsEnvarsus®, Prograf
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
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

14 authors at 6 institutions in 1 country.

Sinem KaraterziDepartment of Pediatrics II, University Hospital of Essen, Essen, Germany.
Burkhard TönshoffDepartment of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
Thurid Ahlenstiel-GrunowDepartment of Pediatrics II, University Hospital of Essen, Essen, Germany.
Maral BaghaiDepartment of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
Bodo BeckInstitute of Human Genetics, University Hospital of Cologne, Cologne, Germany.
Anja BüscherDepartment of Pediatrics II, University Hospital of Essen, Essen, Germany.
Lisa EiflerChildren's and Adolescents' Hospital, Pediatric Nephrology, University Hospital of Cologne, Cologne, Germany.
Thomas GieseDepartment of Immunology, University Hospital Heidelberg, Heidelberg, Germany.
Susanne LeziusInstitute of Medical Biometry and Epidemiology, University Hospital Eppendorf, Hamburg, Germany.
Carsten MüllerPharmacology at the Laboratory Diagnostics Centre, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Jun OhDepartment of Pediatric Nephrology and Gastroenterology, University Hospital Eppendorf, Hamburg, Germany.
Antonia ZapfInstitute of Medical Biometry and Epidemiology, University Hospital Eppendorf, Hamburg, Germany.
Lutz T Weber *Children's and Adolescents' Hospital, Pediatric Nephrology, University Hospital of Cologne, Cologne, Germany.
Lars Pape *Department of Pediatrics II, University Hospital of Essen, Essen, Germany.
Essen University Hospital · DEUniversity Hospital Cologne · DEUniversity Hospital Heidelberg · DEUniversity Medical Center Hamburg-Eppendorf · DEHeidelberg University · DEUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Tacrolimus, a calcineurin inhibitor (CNI), is currently the first-line immunosuppressive agent in kidney transplantation. The therapeutic index of tacrolimus is narrow due to due to the substantial impact of minor variations in drug concentration or exposure on clinical outcomes (i.e., nephrotoxicity), and it has a highly variable intra- and inter-individual bioavailability. Non-adherence to immunosuppressants is associated with rejection after kidney transplantation, which is the main cause of long-term graft loss. Once-daily formulations have been shown to significantly improve adherence compared to twice-daily dosing. Envarsus Methods/design: The study is designed as a randomized, prospective crossover trial. Each patient undergoes two treatment sequences: sequence 1 includes 4 weeks of Envarsus Discussion: This study will test the hypothesis that once-daily prolonged-release tacrolimus (Envarsus Clinical Trial Registration: EUDRA-CT 2019-003710-13 and ClinicalTrial.gov, identifier NCT06057545.

Indexed as

adherenceEnvarsus®kidney transplantationpharmacodynamicspharmacogeneticspharmacokineticsPrograf®tacrolimus

Identifiers

PMID38444519
PMCPMC10912931
OpenAlexW4391963473

What OpenQuestion holds

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LicenceCC BY
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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.