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Pharmacokinetic study of rectal tacrolimus


- candidate number22819
- NTR NumberNTR5450
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2015
- Secondary IDsNL 2014-002425-35 
- Public TitlePharmacokinetic study of rectal tacrolimus
- Scientific TitleA Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole
- ACRONYMSpartacus Brindisi
- hypothesisDetermination of tacrolimus bioavailability after administration as rectiole
- Healt Condition(s) or Problem(s) studiedTransplantation, Tacrolimus, Pharmacodynamics
- Inclusion criteriaPatients ≥18 years
Patients admitted to the department of Intensive Care of UMC Utrecht
Patients eligible for intravenous tacrolimus therapy
Informed consent obtained
- Exclusion criteriaPatients <18 years
Withdrawal of informed consent
Allergy towards tacrolimus or macrolides
Patients on total parenteral nutrition
Pregnancy
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-okt-2017
- Target number of participants8
- InterventionsThe administration of tacrolimus via a rectiole (≤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 on whole blood tacrolimus trough concentrations. The administration of the rectiole will only start after obtaining therapeutic or sub-therapeutic whole blood tacrolimus concentrations via the intravenous route.
- Primary outcomeThe main study parameter is the bioavailability of rectally administered tacrolimus.
- Secondary outcomeThe 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.
- TimepointsOur aim is to include 8 patients within one year. When after one year a minimal number of 6 patients is included, the study will be stopped.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. M.A. Sikma
- CONTACT for SCIENTIFIC QUERIESMD. M.A. Sikma
- Sponsor/Initiator National Poisons Information Center Division of Anesthesiology, Intensive Care and Emergency Medicine, University Medical Center Utrecht
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsSikma MA, van Maarseveen EM, van de Graaf EA, Kirkels JH, Verhaar MC, Donker DW, Kesecioglu J, Meulenbelt J. and Toxicity of Tacrolimus Early After Heart and Lung Transplantation. Am J Transplant. 2015 Sep;15(9):2301-13. doi: 10.1111/ajt.13309. Epub 2015 Jun 4.
- Brief summaryRationale: Tacrolimus is generally orally administered. Absorption of tacrolimus is often disturbed due to gut dysmotility, which is frequently observed shortly after transplantation or in case of septic shock. This can result in rejection and toxicity of tacrolimus. Therefore, in these cases tacrolimus is administered intravenously. The intravenous administration has its disadvantages due to nephrotoxicity of the dissolvent. Consequently, another route of administration is preferable. For this reason, we planned to study whether tacrolimus administration via a rectiole would be an appropriate alternative route.

Objective: To determine the tacrolimus bioavailability after administration as rectiole.

Study design: We will perform a multiple doses, prospective, open-labeled and single-centered pilot study in patients treated with tacrolimus via a rectiole. Whole blood tacrolimus concentrations will be analyzed on the first day, when tacrolimus administration will be intravenously and from the second to the third day, when tacrolimus is administered via a rectiole. Pharmacokinetic parameters will be estimated, such as F, Cmax, Cmin, Tmax, T1/2, Vd and AUC.

Study population: All patients will be included, which are 18 years of age or older, admitted to the department of Intensive Care of UMC Utrecht, treated with tacrolimus and qualifying for intravenous administration.

Intervention: The administration of tacrolimus via a rectiole (≤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 on whole blood tacrolimus trough concentrations. The administration of the rectiole will only start after obtaining therapeutic or sub-therapeutic whole blood tacrolimus concentrations via the intravenous route.

Main study parameters: The main study parameter is the bioavailability of rectally administered tacrolimus. 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.
- Main changes (audit trail)
- RECORD1-sep-2015 - 22-nov-2015


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