Study to evaluate the efficacy and side effects of Envarsus in patients who had a kidney transplantation - PURE study

Amsterdam UMC0 个研究点目标入组 25 人开始时间: 2021年6月24日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•a. Patients aged 18 to 70 years, inclusive, with a stable renal function.
•b. Patients who are at least 6 months until two years after first transplantation, who are not immunized with therapeutic tacrolimus concentrations between 5-8 ng/L and on a stable tacrolimus dose with Tacrolimus-Extended-Release with a C/D ratio < 1.05 ng/mL×1/mg.
•c. Patients must provide written informed consent.
•d. Patients of childbearing potential must agree to use highly effective methods of contraception during the study.
•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 22
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•a. Patient received or is receiving treatment for acute rejection prior to initiation of study.
•b. Donor Specific antibody positivity and patients who are immunized.
•c. Chronic diarrhoea.
•d. Use of protease inhibitors or miconazoles or sedatives.
•e Thyroid dysfunction.
•f. Psychiatric or neurological history or use of psychotropic drugs.
•g.Use of Beta2-agonists or anti-epileptic drugs.
•h. Excessive use of caffeine (more than use of 5 IE daily).
•i. Excessive use of alcohol (more than 2 IE daily).
•j. Patients who are pregnant.

发起方

Amsterdam UMC