Evidence map›Paper›PMID 42252139›Full record

ArticleBMJ open2026

ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiome modulations After kidney transplantation (ENIGMA): study protocol of a prospective longitudinal trial.

Alice Barbé, Lidvine Boland, Nada Kanaan, Tom Darius, Antoine Buemi, Yannick France, Marie-Agnès Ronsyn, Sarah Rahal, Maxime Lingurski, Françoise Van Bambeke and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Alice BarbéDepartment of Integrated PharmacoMetrics, PharmacoGenetics and PharmacoKinetics Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.
Lidvine BolandDepartment of Integrated PharmacoMetrics, PharmacoGenetics and PharmacoKinetics Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.ORCID http://orcid.org/0000-0002-6390-829X
Nada KanaanDepartment of Nephrology, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Tom DariusSurgery and Abdominal Transplant Unit, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Antoine BuemiSurgery and Abdominal Transplant Unit, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Yannick FranceSurgery and Abdominal Transplant Unit, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Marie-Agnès RonsynDepartment of Nephrology, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Sarah RahalDepartment of Nephrology, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Maxime LingurskiDepartment of Integrated PharmacoMetrics, PharmacoGenetics and PharmacoKinetics Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.
Françoise Van BambekeCellular and Molecular Pharmacology Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.
Laure B BindelsMetabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.
Vincent HaufroidDepartment of Clinical Chemistry, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Arnaud DevresseNephrology Department, Institut de Recherche Experimentale et Clinique, Université catholique de Louvain, Brussels, Belgium.
Laure ElensDepartment of Integrated PharmacoMetrics, PharmacoGenetics and PharmacoKinetics Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium laure.elens@uclouvain.be.ORCID http://orcid.org/0000-0002-0039-3583

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn kidney transplantation, immunosuppressive therapy is essential to control alloimmune reactions, prevent graft rejection and improve patient survival rates. However, commonly used drugs like tacrolimus (TAC) and mycophenolate mofetil (MMF) have a narrow therapeutic window and exhibit significant inter- and intra-individual variability in pharmacokinetics (PK) and dose-response relationships. Recent pilot studies suggest that the gut microbiome may influence this variability. METHODS AND ANALYSIS: ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiome modulations After kidney transplantation (ENIGMA) is a prospective, low-interventional, naturalistic longitudinal trial designed to identify biomarkers of TAC and MMF PK variability by examining gut microbiome changes and modulations after kidney transplantation and their link with TAC and MMF PK. Biological samples from 50 patients will be collected at nine specific timepoints pre- and post-transplantation using a rich PK and biological sampling strategy. This approach will enable the derivation of PK parameters for the investigated drugs and the creation of a biobank for future hypothesis testing. ETHICS AND DISSEMINATION: The ENIGMA trial has received ethical approval from the European Medicines Agency (EMA). The reference number of our project is R&D/1325226 and is registered on the Clinical Trial Information System (CTIS) platform with European Union Clinical Trial number 2023-5 08 335-31-00. Results of the trial will be published in scientific journals and presented at different (inter)national conferences. TRIAL REGISTRATION NUMBER: 2023-5 08 335-31-00 EMA.

Indexed as

Gastrointestinal MicrobiomeGraft RejectionImmunosuppressive AgentsKidney TransplantationMycophenolic AcidTacrolimusFemaleHumansLongitudinal StudiesProspective StudiesImmunosuppressive AgentsMycophenolic AcidTacrolimusAntibioticsCLINICAL PHARMACOLOGYGastrointestinal MicrobiomeImmunityRenal transplantation

Identifiers

PMID42252139
PMCPMC13250183

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Registered trials

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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.