EUCTR2014-004314-29-DE进行中（未招募）1 期
MULTICENTRE, OPEN LABEL, RANDOMIZED, TWO-ARM, PARALLEL-GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF ENVARSUS® COMPARED WITH TACROLIMUS USED AS PER CURRENT CLINICAL PRACTICE IN THE INITIAL MAINTENANCE SETTING IN DE NOVO KIDNEY TRANSPLANT PATIENTS. - STEADY study
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
- 400
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. Patient's signed informed consent obtained prior to any study-related
- •2. Adult men and women at least 18 years of age with end-stage renal
- •disease who are recipients (or will be recipients) of a kidney transplant from a living or
- •deceased donor;
- •3. No known contraindications to the administration of tacrolimus, other
- •macrolides and study drugs excipients;
- •4. Patients must agree to use a highly reliable method of birth control;
- •5. Donor-recipient negative cross match test, and compatible ABO blood type;
- •6. Able to swallow tablets and capsules.
- •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 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Recipient of any transplanted organ other than kidney;
- •2. Recipient of a previous renal transplant;
- •3. Recipient of a kidney from a donor after cardiac death;
- •4. Recipient of a kidney from an ABO incompatible donor and positive cross-match donor;
- •5. Current (not older than 3 months) anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%. Whenever PRA, either complement-dependent cytotoxicity-PRA or calculated-PRA, is not available, patients who are positive on solid-phase screening assays for anti-HLA antibodies must not be enrolled
- •6. Recipient of a kidney with a cold ischemia time of = 30 hours;
- •7. White blood cells count = 2.8x109 cells/L unless ANC >1.0x109/L;
- •8. Platelet count < 50 x109 cells/L;
- •9. ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;
- •10. Current abuse of drugs or alcohol;
- •11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
- •12. Treatment with any other investigational agent in the 30 days prior to enrolment;
- •13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
- •14. Kidney recipients and/or donors positive for HBV (HBV-DNA and/or HBS-Ag positive);
- •15. Recipients positive for HIV;
- •16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
- •17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
- •18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
- •19. Known hypersensitivity to tacrolimus; other macrolides and study
- •drugs excipients
- •20. Pregnant or lactating women and all women physiologically capable
- •of becoming pregnant (i.e. women of childbearing potential) UNLESS are
- •willing to use one or more of the following reliable methods of contraception:
- •a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •b. Hormonal contraception (implantable, injectable, patch, oral)
- •c. Double barrier methods of contraception: condom and occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository
- •The use of diaphragm is allowed only if in combination with a chemical contraceptive (ie, ointments, gels, suppositories, tablets, foam or sprays that contain spermicides). Condoms must not be used with lubricant and oils.
- •d. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- •21. Persons who have been housed in an institution due to a government or judicial order;
- •22. Persons who are dependent on the sponsor, the investigator or the trial site
研究者
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