Influence of Antimicrobial Drugs on Mycophenolic acid and Tacrolimus Pharmacokinetics and the Gut Microbiome in Kidney Transplant Recipients (AXIS)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-527106-20-00

Enrollment

120

Registered

2026-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation

Brief summary

AUC0-12/0-24 and Cmax ratios of Tac with:without antimicrobial treatment, AUC0-12/0-24 and Cmax ratios of MPA with:without antimicrobial treatment

Detailed description

Tac and MPA pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, population pharmacokinetic model parameters, genotype of relevant drug metabolizing enzymes and transporters, taxonomic diversity in fecal metagenomes, microbiome-derived ex vivo drug reactivation/conversion rates, ARGs

Interventions

DRUGCellCept 500 mg film-coated tablets

DRUGMycophenolate mofetil Accord 500 mg filmdragerade tabletter

DRUGAdvagraf 1 mg prolonged-release hard capsules

DRUGPROGRAF 1 mg capsule

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AUC0-12/0-24 and Cmax ratios of Tac with:without antimicrobial treatment, AUC0-12/0-24 and Cmax ratios of MPA with:without antimicrobial treatment	—

Secondary

Measure	Time frame
Tac and MPA pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, population pharmacokinetic model parameters, genotype of relevant drug metabolizing enzymes and transporters, taxonomic diversity in fecal metagenomes, microbiome-derived ex vivo drug reactivation/conversion rates, ARGs	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 22, 2026