Within-patient variability in tacrolimus pharmacokinetics in renal transplant patients treated with different tacrolimus formulations. - IPV of tacrolimus formulations.

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Subjects are eligible for the study if all of the following apply:
•1. Age * 18 years.
•2. Kidney transplant at least 12 months prior to enrollment and clinically stable in the opinion of the investigator.
•3. Prograft® based immunosuppressive regimen.
•4. Prograft® dose unchanged for a minimum of 12 weeks prior to enrollment.
•5. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 12 weeks prior to enrollment.
•6. Female subject of childbearing potential must agree to practice effective birth control during the study.
•7. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent Form has been obtained).

•Subjects will be excluded from participation if any of the following apply:
•1. Previously received an organ transplant other than a kidney.
•2. Acute rejection episode within 6 months prior to enrolment, or an acute rejection episode within the 12 months prior to enrolment that required anti-lymphocyte antibody therapy.
•3. Diagnosis of new-onset malignancy after transplantation, with the exception of basocellular or squamous cell carcinoma of the skin, which have been treated successfully.
•4. Known allergy to the study drug or any of its components.
•5. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
•6. Active participation in another clinical trial.
•7. Unlikely to comply with the visits scheduled in the protocol.
•8.. Previous treatment with Envarsus or Advagraf.

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