Comparison of pharmacokinetic (PK) levels before and after conversion from twice-daily tacrolimus to once-daily extended-release tacrolimus (LCPT) in diabetic transplant recipients - SPK-PK

CHU de Nantes0 个研究点目标入组 25 人开始时间: 2020年1月27日最近更新: 2021年4月5日

试验速览

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•Patient is willing and able to give informed consent for participation in the trial.
•Male or Female, aged 18 years or above.
•Recipient of kidney and pancreas-transplant
•Both transplants are functioning at time of PK profile measurements
•Standard immunosuppressive therapy has been started post-operatively, in accordance with local policy, including tacrolimus.
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Patients with social security.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Patient is inappropriate for standard immunosuppressive therapy.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
•Concomitant therapy with drugs potentially interfering with tacrolimus pharmacokinetics, especially those interfering with CYP3A4 (see 4.4 section in tacrolimus / l’ENVARSUS® summary of product characteristics).
•Pregnant or breast-feeding women and female patient with potential childbearing refusing contraception.
•Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship.

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