PHASE IV, OPEN, UNICENTRIC AND PILOT CLINICAL TRIAL TO EVALUATE THE INFLUENCE ON THE BIODISPONIBILITY AND PHARMACOKINETIC CHARACTERISTICS OF ENVARSUS® COMPARED WITH ADVAGRAF® OF FAST OR INGESTIONIN STABLE PATIENTS WITH RENAL TRANSPLANTATIO

Consorci Mar Parc de Salut0 个研究点目标入组 16 人开始时间: 2018年1月30日最近更新: 2018年6月18日

试验速览

暂无简介。

•1. Patients with a stable kidney transplant after the first year of the transplant, with low immunological risk.
•2. At least during the last 3 months before entering the trial, both the 8 patients treated with Advagraf® and the 8 patients treated with Envarsus® should not have presented relevant changes in the dose (consider relevant changes> 1 mg in dose) and blood levels should be between 4 and 10 ng / ml.
•3. Patients treated with Myfortic® that have not presented relevant changes in the dose, during the last 3 months before entering the study.
•4. Patients treated with a dose of Prednisone of 5 mg / day at least during the 3 months before entering the study.
•5. Patients =18 years.
•6. Caucasian patients.
•7. BMI between 18.5-29.9 Kg / m2.
•8. Patient who have given their written consent to participate in the trial.
•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 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Drug interaction that may interfere with the bioavailability of tacrolimus (Annex 1).
•2. Patients with a history of neoplasic gastrointestinal disease (gastrointestinal disease or gastrointestinal surgery)
•3. Changes in intestinal transit (diarrhea or constipation), or any significant increase in bowel movements per day during the last week of inclusion in the trial.

发起方

Consorci Mar Parc de Salut