EUCTR2005-001348-22-DE进行中（未招募）不适用
AN OPEN, RANDOMISED, MULTICENTRE CLINICAL STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF STEROID WITHDRAWAL WITH TACROLIMUS, MYCOPHENOLATE MOFETIL AND DACLIZUMAB AGAINST TACROLIMUS, MYCOPHENOLATE MOFETIL AND STEROIDS IN CHILDREN AFTER KIDNEY TRANSPLANTATION - TWIST study
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
- 200
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 patient younger than 18 but not younger than 2 years of age, regardless of race.
- •2. Skeletal age of boys = 17, girls = 15 years
- •3. Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation.
- •4. Patient is receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type.
- •5. Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) during the study and 6 weeks thereafter.
- •6. The patient, or in case the patient is minor, the patients parent(s) or their legal representative, has been fully informed and has given written informed consent to participate in the study. If the minor is in the position to comprehend the nature, significance and scope of the study and to determine his decision accordingly, then his written consent shall also be required. Witnessed informed consent is accepted in case the patient (if not a minor) is capable of making the decision but not capable of signing the document.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 most recently measured PRA grade of = 50% within the previous six months and/or having a retransplantation due to immunological reason.
- •2. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, tacrolimus, mycophenolate mofetil, mycophenolic acid, daclizumab and/or to the excipients of the study medication.
- •3. Patient requires ongoing dosing with corticosteroids.
- •4. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication.
- •5. Patient and/or donor is known to be HIV positive.
- •6. Patient has significant liver disease, defined as having during the past 28 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.
- •7. Patient with malignancy or history of malignancy except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- •8. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting or active peptic ulcer.
- •9. Patient has previously received or is receiving an organ transplant other than kidney.
- •10. Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 28 days before entry into this study.
- •11. Patient has been previously enrolled in this study.
- •12. Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.
- •13. Patient is unlikely to comply with the visits scheduled in the protocol.
- •14. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator
- •15. Patient is pregnant or a breast-feeding mother.
研究者
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