EUCTR2016-000340-34-ES进行中（未招募）1 期
Dose optimization of tacrolimus using Bayesian prediction including pharmacogenetic variables in renal transplant patients. - OPTIMUS
HOSPITAL UNIVERSITARI DE BELLVITGE0 个研究点开始时间: 2016年4月20日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Adult patients (? 18 years).
- •? Recipients of a renal graft from a cadaveric or living donor with more than 6 months post-transplant evolution.
- •? Patients who received a non-interrupted stable oral dose of immediate release tacrolimus (Prograf / Adoport®) and have had stable TAC trough concentrations between 6-10ng / ml for at least 10 days (steady state conditions).
- •? Patients receiving allowed concomitant immunosuppressive medication : mofetil or sodium mycophenolate and corticosteroids.
- •? May receive induction therapy with basiliximab.
- •? Subjects must be willing to give written informed consent for the trial. If a subject can not give written informed consent, a legal representative can sign instead.
- •? Women of childbearing potential should have a negative pregnancy test result at the time of inclusion and accept the use of a medically acceptable method of contraception during the selection and while receiving medication specified in the protocol.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •? Patients on dialysis or treatment of rejection after transplantation.
- •? Patients treated with substances with potential interaction with TAC, particularly potent inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin or rifabutin).
- •? Patients with induction therapy with ATG or rituxumab.
- •? Patients participating in another clinical trial or who were treated with any investigational drug within 30 days prior to inclusion.
- •? Patients with liver disease.
- •? Patient or donor with a current diagnosis or history of malignancy within the last 5 years except non-metastatic basal or squamous cell skin carcinoma successfully treated.
- •? Pregnant or lactating women and all women of childbearing potential unless they use reliable contraception. A pregnancy test will be performed in the selection and end of the study.
- •? Recipient of any other organ apart from kidney.
- •? Recipients of bone marrow or stem cell transplant.
- •? Recipients of a kidney from a ABO incompatible donor.
- •? Patients with donor specific anti-HLA antibodies.
- •? Anticipated cold ischemia time of ? 24 hours.
- •? Patients with a concomitant uncontrolled infection, systemic infection requiring treatment, or any other unstable medical condition that may interfere with the study objectives.
- •? Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of TAC.
- •? Patients with white blood cell count ? 2.8 x 109 / L unless the absolute neutrophil count (ANC) is ? 1.0 x 109 / L
- •? Patients with platelet count ? 50 x 109 / L.
- •? Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding> 3 times the upper limit of normal during the 30 days prior to the transplant procedure.
- •? Patients with known hypersensitivity to TAC or any of the excipients in the formulation
- •? Patients unable to swallow study medication.
- •? Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the investigator's opinion, may invalidate the communication with the investigator.
- •? Patients who require a high intake of potassium or potassium-sparing diuretics.
- •? Patients treated with substances with known nephrotoxic or neurotoxic effects.
- •? Recipients that are positive for hepatitis C virus (HCV-RNA positive) and / or hepatitis B virus (HBV DNA or HBsAg positive).
- •? Recipients positive for human immunodeficiency virus (HIV-Ab positive).
- •? Patients unable to understand the effects and risks of the study, who can not give informed consent in writing, or who are unwilling to comply with the study protocol patients.
研究者
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