EUCTR2004-000457-34-SE进行中（未招募）不适用
A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION THERAPY OF TACROLIMUS WITH SIROLIMUS VERSUS TACROLIMUS WITH MYCOPHENOLATE MOFETIL IN KIDNEY TRANSPLANTATION - RESTORE(Regimen Evaluation Study with Tacrolimus Observing Renal Efficacy)
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
- 600
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 between 18 and 60 years of age.
- •2.Female patient of childbearing potential agrees to maintain effective birth control during the study and 3 months thereafter.
- •3.Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation (unless the graft was lost from rejection within 12 months).
- •4.Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor with compatible AB0 blood type.
- •5.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent. 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 in writing 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has a high immunological risk, defined as a PRA grade >50% in the previous 6 months and / or having a previous graft survival < 1 year due to immunological reason.
- •2. Patient is receiving a graft from a non-heart-beating donor.
- •3. Cold ischemia time of the donor kidney greater than 30 hours.
- •4. Patient has significant liver disease, defined as having during the past 30 days continuously elevated AST (SGOT) and/or ALT (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.
- •5. Patient has severe hypercholesterolaemia (cholesterol >350mg/dL, 9.1 mmol/dL). Patient with controlled hyperlipidemia is acceptable.
- •6. Patient is pregnant or breastfeeding.
- •7. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, sirolimus or to the excipients of the study medication.
- •8. Patient requires ongoing dosing with corticosteroids.
- •9. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.6).
- •10. Patient or donor is known to be HIV positive.
- •11. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- •12. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- •13. 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.
- •14. Patient has previously received or is receiving an organ transplant other than kidney.
- •15. Patient has been previously enrolled in this study.
- •16. Patient is unlikely to comply with the visits scheduled in the protocol.
- •17. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
研究者
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