EUCTR2007-001821-85-SE进行中（未招募）不适用
A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 690
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
- •Ability and willingness to provide written informed consent and adhere to study regimen.
- •Recipients who are 18-70 years of age of a primary liver transplant from a deceased donor.
- •Recipients who have been initiated on an immunosuppressive regimen that contains corticosteroids and tacrolimus, 3-7 days post-transplantation.
- •Confirmed recipient HCV status at Screening (either by antibody or by PCR).
- •Allograft is functioning at an acceptable level by the time of randomization as defined by AST, ALT, Total Bilirubin levels =3 times ULN and AlkP and GGT = 5 times ULN. PER AM1- Elevated GGT alone, in combination with AST, ALT, total bilirubin and AlkP within the defined range does not exclude patients from randomization.
- •Abbreviated MDRD eGFR = 30 mL/min/1.73m2. PER AM 1 Local and central serum creatinine results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation.
- •Verification of at least one tacrolimus trough level of = 8 ng/mL in the week prior to randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels above 8 ng/mL prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 640
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Patients who have a combined liver-kidney transplant.
- •Recipients of a liver from a living donor, or of a split liver.
- •History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin, or HCC (see next criteria).
- •Hepatocellular carcinoma that does not fulfill Milan criteria at the time of transplantation as per explant histology of the recipient liver.
- •Any use of antibody induction therapy.
- •Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients
- •Patients who are recipients of ABO incompatible transplant grafts.
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen or HIV are excluded.
- •Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug.
- •Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed).
- •PER AM1 Patients wITH A CONFIRMED spot urine protein/creatinine ratio that indicates = 1.0 g/24 hrs of proteinuria at baseline,AND THAT CANNOT BE EXPLAINED BY IMMEDIATE POST OPERATIVE EFFECTS.
- •Use of immunosuppressive agents or treatments after baseline that are not utilized in the protocol.
- •Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) within 6 months of transplantation. Patients with controlled hyperlipidemia are acceptable at the time of randomization.
- •Patients with platelet count < 50,000/mm3 at the time of randomization.
- •Patients with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³ at the time of randomization.
- •Patients who are unable to take oral medication at time of randomization.
- •Patients who have tested positive for HIV. Negative laboratory results obtained within 6 months prior to randomization are acceptable.
- •Patients with clinically significant systemic infection requiring active use of IV antibiotics at the time of randomization.
- •Patients who are in a critical care setting at the time of randomization requiring life support measures such as mechanical ventilation, dialysis, requirement of vasopressor agents.
- •Patients who require renal replacement therapy for clearance within 7 days prior to randomization.
- •The presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic veins, portal vein and inferior vena cava. Results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation.
- •An episode of acute rejection that required antibody therapy or more than one steroid-sensitive episode of acute rejection during the run-in period. This includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
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