EUCTR2004-000520-32-ES进行中（未招募）1 期
A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION OF TACROLIMUS AND MYCOPHENOLATE MOFETIL BASED REGIMEN WITH OR WITHOUT INDUCTION IN ELDERLY RECIPIENTS UNDERGOING KIDNEY TRANSPLANTATION - SENIOR (Safety and Efficacy with kNown Immunosuppression in Older Recipients)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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 Male or female patients minimum 60 years of age
- •2 Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- •3. Patient is receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type
- •4. Patient has been fully informed and has given written informed consent according to ICH-GCP. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed by an independent person
- •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. Patient has an immunological high risk, defined as a PRA grade >50%
- •2. Cold ischemia time of the donor kidney greater than 30 hours
- •3. Patient has significant liver disease, defined as having during the past 30 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
- •4. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, basiliximab or to the excipients of the study medication
- •5. Patient requires ongoing dosing with corticosteroids
- •6. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.4 of protocol)
- •7. Patient or donor is known to be HIV positive
- •8. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- •9. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- •10. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days
- •11. Patient has previously received or is receiving an organ transplant other than kidney
- •12. Patient has been previously enrolled in this study
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