A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving either RAD001 (everolimus) plus reduced TAC or RAD001 (everolimus) plus MMF - not applicable

ovartis Pharma GmbH0 个研究点开始时间: 2015年7月1日最近更新: 2015年10月12日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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 at Screening Visit (Visit 1):
•1. Patients willing and capable of providing written informed consent for study participation and able to participate in the study.
•2. Adults 18 to 70 years of age at the time of inclusion, who received a primary liver allo¬graft from a deceased or living donor and are treated with a CNI containing immuno¬sup¬pres¬sive regimen.
•3. Patients who had a liver transplant 6 to 24 months prior to Screening.
•4. Estimated kidney function (MDRD 4) between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function (at the in¬ves¬ti-ga¬tor’s discretion), indicated by earlier local laboratory assessments not older than 3 months previous to Screening.
•5. Acceptable graft function (aspartate amino transferase (AST), alanine aminotransferase (ALT) and total bilirubin = 3 × upper limit of normal (ULN) and alkaline phosphatase (ALP) = 5 × ULN), indicated by earlier local laboratory assessments not older than 3 months previous to Screening.
•Inclusion criteria at Baseline Visit (Visit 2):
•1. Estimated kidney function (MDRD 4) between CKD IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function (at the investigator’s discretion).
•2. Acceptable graft function (AST, ALT and total bilirubin = 3 × ULN and ALP = 5 × 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 600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

排除标准

•Exclusion criteria at Screening Visit (Visit 1):
•1. Recipient of multiple solid organ transplants.
•2. Patients with active chronic inflammatory bowel disease and recurrent autoimmune hepatitis (at the investigator’s discretion).
•3. Patients with an mTOR-inhibitor based immunosuppressive therapy.
•4. Patient with an identifiable cause of renal dysfunction other than CNI toxicity.
•5. Patients who have any sign of malignant diseases other than neoplasms of the skin.
•6. Patient who has received an unlicensed drug / therapy within one month prior to study entry or presence of any hypersensitivity to drugs similar to everolimus (e.g. macrolides).
•7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG la¬bo-ra¬tory test.
•8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
•Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
•Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
•Male sterilization (at least 6 months prior to Screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
•Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cer¬vi-cal/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository.
•Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of three months.
•Placement of an intrauterine device (IUD) or intrauterine system (IUS).
•Exclusion criteria at Baseline Visit (Visit 2):
•1. Patients with clinically significant or uncontrolled systemic infection requiring active use of intravenous antibiotics/antivirals at baseline.
•2. Patients who are in a critical care setting at the time of baseline requiring life support measures, such as mechanical ventilation and dialysis.
•3. Patient with platelet count = 50 000/mm3, white blood cell (WBC) count = 3 000/mm3, ab-so¬lute neutrophil count = 1 000/mm3 and hemoglobin = 8 g/dL.
•4. Patients with more than one acute rejection 6 months prior to baseline and any acute re-jection within 6 weeks prior to baseline.
•5. Patients with uncontrolled hyperlipidemia or proteinuria = 1.0 g/ 24 h (Protein/Creatinine-Ratio).
•6. Hepatitis C virus positive patient who needs an active antiviral treatment and/or human immuno¬deficiency virus (HIV) positive patient. Negative laboratory results for HIV ob-tained 6 months prior to baseline are acceptable.

研究者

发起方

ovartis Pharma GmbH

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