NL-OMON44149撤回4 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 - Chiesi_CCD-06235AA1-01 [acronym STEADY]
Chiesi Farmaceutici0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 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
- •6. Able to swallow tablets and capsules.
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 anti-HLA Panel Reactive Antibody (PRA) levels higher than
- •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 reliable methods of contraception.
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