Pharmacokinetic study of rectal tacrolimus

A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28377

Enrollment

Registered

2015-09-01

Start date

2015-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

tacrolimus, pharmacokinetics, bioavailability, toxicity, transplantation

Interventions

The administration of tacrolimus via a rectiole (&#8804

100% bioavailability) will initially start twice a day in a 1:1 relation to the intravenous administration (100% bioavailability) (0.025 mg/kg divided in 2 doses per day). Doses will be adjusted based

Eligibility

Inclusion criteria

Inclusion criteria: Patients ≥18 years Patients admitted to the department of Intensive Care of UMC Utrecht Patients eligible for intravenous tacrolimus therapy Informed consent obtained

Exclusion criteria

Exclusion criteria: Patients <18 years Withdrawal of informed consent Allergy towards tacrolimus or macrolides Patients on total parenteral nutrition Pregnancy

Design outcomes

Primary

Measure	Time frame
The main study parameter is the bioavailability of rectally administered tacrolimus.	—

Secondary

Measure	Time frame
The concentration-time curves will be used to calculate the AUC0-12h, in order to estimate the bioavailability (F): Other study parameters are Cmax, Cmin, Tmax, Vd, T1/2, and AUC.	—

Contacts

Public ContactM.A. Sikma

National Poisons Information Center and Intensive Care Center of the division of Anesthesiology Intensive Care and Emergency Medicine University Medical Center of Utrecht F06.149 P.O. Box 85500

m.a.sikma@umcutrecht.nl+31 (0)88 7555555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)