interventional
N/A
1 country
1
To investigate the effect of treatment with antimicrobial drugs on the PK of tacrolimus (Tac) and mycophenolate mofetil (MMF) in kidney transplant recipients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2026
Actual (reported)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
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
CellCept 500 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
Mycophenolate mofetil Accord 500 mg filmdragerade tabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
Advagraf 1 mg prolonged-release hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE CAPSULE, HARD
View registry recordFormulated product
PROGRAF 1 mg capsule
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
CellCept 500 mg film-coated tablets
Named ingredient: Mycophenolate mofetil
View registry recordMycophenolate mofetil Accord 500 mg filmdragerade tabletter
Named ingredient: Mycophenolate mofetil
View registry recordAdvagraf 1 mg prolonged-release hard capsules
Named ingredient: Tacrolimus
View registry recordPROGRAF 1 mg capsule
Named ingredient: Tacrolimus
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Oslo Universitetssykehus HF
Oslo, 0372, Norway
Anders Åsberg
First Submitted
June 23, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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