EUCTR2015-005275-24-ES进行中（未招募）不适用
Conversion pharmacodynamic study in stable renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day. - TACPKPD
HOSPITAL UNIVERSITARI DE BELLVITGE0 个研究点开始时间: 2016年2月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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).
- •? Receivers cadaveric renal graft or living donor with more than 6 months post-transplant evolution.
- •? Patients receiving Prograf stable and stable TAC trough concentrations between 5-10ng / ml non-interrupted oral dose for at least 10 days (steady state conditions).
- •? receiving concomitant immunosuppressive medication allowed: sodium or mycophenolate mofetil and corticosteroids.
- •? Subjects must be willing to give their written informed consent to testing and be able to do consent. If a subject can not give written informed consent independently, you can do your legal representative instead.
- •? Women of childbearing age must undergo a pregnancy test at the time of inclusion and accept the use of a medically acceptable method of contraception during the selection and receive medication as 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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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 participating in another clinical trial or treated with any investigational drug within 30 days prior to inclusion.
- •? Patients with liver disease.
- •? The patient or donor with the current diagnosis or history of malignancy within the past 5 years except carcinoma nonmetastatic basal or squamous cell skin treated successfully.
- •? pregnant or breast-feeding women and all women of childbearing age unless they use reliable contraception. A pregnancy test will be performed at screening and at the end of the study.
- •? Receiver of any other organ transplanted kidney.
- •? The recipients of bone marrow or stem cell transplant.
- •? Recipients of a kidney from a donor ABO incompatible.
- •? Patients with donor specific anti-HLA antibodies.
- •? Recipients of a kidney with anticipated cold ischemia time of ? 24 hours.
- •? Patients with concomitant uncontrolled infection, systemic infection in treatment, or any other unstable medical condition that could interfere with the study objectives.
- •? Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that can 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 levels of 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 Envarsus®.
- •? unable to swallow study medication patients.
- •? 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.
- •? positive for hepatitis C virus (HCV-RNA positive) and / or hepatitis B virus (HBV DNA or HBsAg positive) receivers.
- •? positive for human immunodeficiency virus (HIV-Ab positive) receivers.
- •? unable to understand the effects and risks of the study, who can not give informed consent in writing or unwilling to comply with the study protocol patients
研究者
相似试验
已完成
4 期
The role of renal function in the pharmacokinetics and safety of remdesivir in COVID-19 patientsNL-OMON51092HagaZiekenhuis60
已完成
1 期
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal FunctionRenal ImpairmentNCT02508506Alkermes, Inc.22
已完成
1 期
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single and Multiple Doses of Linagliptin Tablets in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal FunctionRenal InsufficiencyNCT02191228Boehringer Ingelheim51
已完成
4 期
Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day.Kidney Transplant ComplicationsNCT02961608Hospital Universitari de Bellvitge25
已完成
1 期
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With and Without Renal ImpairmentRenal InsufficiencyNCT02182024Boehringer Ingelheim35