EUCTR2009-012200-98-DE进行中（未招募）不适用
Open-label, prospective, randomized, parallel group study investigating a CNI-low dose regimen with Sandimmun® Optoral and Certican® in comparison to standard immunosuppressive therapy in renal transplant patients with creeping creatinine.
niversity Medical Center Hamburg-Eppendorf0 个研究点开始时间: 2010年9月24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
- •1.Males or females, aged 18 years and older.
- •2.Maintenance renal transplant recipients at least 6 months post-transplantation, no longer than 8 years after transplantation.
- •3.Patients have to be on an immunosuppressive regimen with 1) Myfortic® (target dose: 1440 mg/day, if tolerated; minimal dose: 720 mg/day) or CellCept® (target dose: 1000 mg/day, if tolerated; minimal dose: 500 mg/day) and 2) Sandimmun® Optoral with or without 3) corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline.
- •4.Patients with a creeping serum creatinine (CAN-Slope®) and with a serum creatinine = 2.5 mg/dL stable for at least one month (according to the investigator) and albuminuria =800 mg/ day.
- •5.Receiving a kidney transplant from a cadaveric or living donor with compatible ABO blood type.
- •6.Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.
- •7.Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons.
- •2.Patients who suffer (at the time of conversion) from severe rejection (more than or equal to BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection.
- •3.Patients with thrombocytopenia (platelets < 75.000/mm³), with an absolute neutrophil count of <1.500/mm³ or leucopenia (leucocytes < 2.500/mm³), or hemoglobin < 6 g/dL.
- •4.Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times ULN).
- •5.Patient with proteinuria > 800 mg/day at baseline.
- •6.Patients with clinically significant infection requiring continued therapy which would interfere with the objectives of the study.
- •7.Patients receiving drugs known to interact with CsA and/or mycophenolic acid and/or everolimus.
- •8.More than one previous renal transplantation.
- •9.Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney.
- •10.Patients with hypersensitivity to Certican®, Sandimmun® Optoral, mycophenolic acid, or other components of the formulation (e.g. lactose).
- •11.Patients who have participated in an investigational trial within four weeks prior to baseline.
- •12.Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.
- •13.Patients with a history of malignancy during the last five years, except squamos or basal cell carcinoma of the skin.
- •14.Patients who are HIV positive, or Hepatitis C-, or Hepatitis B surface antigen positive.
- •15.Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contraception.
- •16.Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study.
- •17.Evidence of drug or alcohol abuse.
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