EUCTR2005-006138-14-DE进行中（未招募）不适用
Multi-center, open-label, prospective, randomized, parallel group study investigating an intensified Myfortic® dosing regimen in comparison to a standard dosing regimen of Myfortic® in combination with Sandimmun® Optoral and Corticosteroids in de novo renal transplant patients - OptiMyze
ovartis Pharma GmbH0 个研究点目标入组 120 人开始时间: 2006年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Inclusion Criteria
- •1. Males or females, aged between 18 and 70 years
- •2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- •3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
- •4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
- •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
- •Exclusion Criteria
- •1. More than one previous renal transplantation
- •2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •3. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •4. Patients receiving a kidney from a non-heart beating donor
- •5. Patients who are recipients of A-B-O incompatible transplants
- •6. Patients with a current peak PRA of > 50%
- •7. Patients with already existing antibodies against the HLA-type of the receiving transplant
- •8. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine A, or other components of the formulations (e.g. lactose, see also SmPCs)
- •9. Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit)
- •10. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 6 g/dL
- •11. Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
- •12. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
- •13. Patients who are HIV positive or Hepatitis B surface antigen positive.
- •14. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •15. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception (see also section 8.2 in the protocol)
- •16. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
- •17. Evidence of drug or alcohol abuse
- •18. Patients receiving drugs known as strong inhibitors or inducers of CsA and/or Myfortic® drug metabolism (for drug interactions see Appendix 3 to this protocol).
研究者
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