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

2026-527106-20-00 · tracked via the Priya Life Science EU tracker

Sponsor

Oslo Universitetssykehus HF

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Microbiological Phenomena

Decision date

21/09/2026

Enrollment target

120

Sites

Norway

Condition studied

Kidney transplantation

Investigational medicinal product(s)

CellCept 500 mg film-coated tabletsMycophenolate mofetil Accord 500 mg filmdragerade tabletterAdvagraf 1 mg prolonged-release hard capsulesPROGRAF 1 mg capsule

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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