EUCTR2011-003118-17-DE进行中（未招募）1 期
A 12 month, multi-center, open-label, randomized, controlled study to evaluate efficacy/safety and evolution of renal function of everolimus in co-exposure with tacrolimus in de novo liver transplant recipients
ovartis Pharma GmbH0 个研究点开始时间: 2012年1月4日最近更新:
适应症
相关药物
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
- •Inclusion Criteria
- •1. Patients who are willing and able to participate in the study and from whom written
- •informed consent has been obtained.
- •2. Male or female recipients of a full-size liver allograft, aged 18 to 65 years.
- •3. Females capable of becoming pregnant must have a negative pregnancy test prior to start
- •of study and before randomization and are required to practice a medically approved
- •method of birth control or live in total abstinence for the duration of the study.
- •Inclusion Criteria - Randomization
- •1. eGFR (MDRD4 formula) > 30 mL/min/1.73m2 at time of randomization.
- •2. Absence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic
- •veins, portal vein and inferior vena cava at time of randomization and prior to any
- •initiation of treatment with everolimus.
- •3. Allograft is functioning at an acceptable level by the time of randomization as defined total bilirubin levels =3 times ULN and AlkP, AST, ALT levels = 5 times ULN.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •Exclusion Criteria:
- •1. HIV positive patients.
- •2. Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant.
- •3. Patients with renal failure or CKD/ESRD who require renal replacement therapy for more than 2 weeks prior to transplantation.
- •4. 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).
- •5. HCC that does not fulfill Milan criteria (1 nodule = 5 cm, 2-3 nodules all = 3 cm) at the time of transplantation.
- •6. Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
- •7. Patients receiving drugs known to significantly interact with any immunosuppressant used in the trial.
- •8. Patients who are recipients of AB0 incompatible transplant grafts.
- •9. Patients with a current systemic infection or sepsis requiring active use of IV antibiotics.
- •10. Patients with symptoms of significant mental illness and with inability to cooperate or communicate with the investigator. Patients who are unlikely to comply with the study requirements, or who are unable to give informed consent.
- •- who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
- •- who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4-8 weeks after the end of treatment. A negative pregnancy test (serum) for all women entering menarche is required with sufficient lead time before inclusion
- •12. Patients, who have already been randomized into this study earlier must not be included a second time.
- •13. Participation in another clinical trial.
- •Exclusion Criteria - Randomization
- •1. Patients who are not able to take oral medication at time of randomization.
- •2. Patients with platelet count <50,000/mm³)
- •3. Patients with an absolute neutrophil count of <1,000/mm³
- •4. Patients with a white blood cell count of <2,000/mm³),
- •5.Patients with hemoglobin < 6.0 g/dL (transfusion of erythrocytes concentrate during or after transplantation are allowed according to investigator discretion)
- •6.Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or
- •hypertriglyceridemia (>300 mg/dL, >8.5 mmol/L).
- •7.Patients with a protein/creatinine ratio indicating daily urinary protein excretion >1 g/24h
- •at time of randomization.
- •8.Patients with clinically significant or uncontrolled systemic infection requiring active use
- •of IV antibiotics at the time of randomization.
- •9.Patients who have received an investigational drug within 30 days prior to randomization.
研究者
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