Effect of Envarsus conversion on tacrolimus-associated tremor in renal transplant patients. An open-label, single centre, prospective pharmacodynamic/pharmacokinetic clinical study

Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2017年5月30日最近更新: 2017年8月21日

试验速览

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•Adult kidney allograft recipients from a deceased or living donor (= 18 years old) who underwent transplantation between 12 and 18 months before inclusion in the study;
•-Patients receiving a stable un-interrupted oral dose of Advagraf® and achieving stable tacrolimus (TAC) trough concentrations between 5-10 ng/mL, since the last visit (steady state conditions);
•-Patients without signs of rejection in the per protocol biopsy performed at month 12 after transplantation;
•-Patients experiencing clinically significant tremor measured by DyCare wireless sensor (a wearable tool to evaluate movement disorders).
•-Patients that have signed the informed consent form.
•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 20

•Patients receptors of simultaneous liver-kindey, heart-kidney or reno-pancreatic transplant;
•-Diagnosis of Parkinson's disease, or other neurological syndromes characterized by the occurrence of tremor;
•-Patients who participated in a clinical trial in the last 30 days;
•-Patient unable to swallow study medication;
•-Current abuse of drugs or alcohol;
•-Patient or donor with current diagnosis or history of malignancy (except basal-cell carcinoma or treated squamous cell carcinoma of the skin);
•-Known hypersensitivity to tacrolimus;
•-Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS willing to use a highly efficacious method of contraception throughout the duration of the study;

发起方

Fundació Clínic per a la Recerca Biomèdica