EUCTR2006-003633-32-AT进行中（未招募）不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patients
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
- 306
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. Males or females, aged between 18 and 65 years
- •2. Recipients of first or second 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 (Visit 1), and are required to practice an approved method of birth control for the duration of the study and for a period of 3 months 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Graft loss due to immunological reasons in the first year after the first transplantation (in case of secondary transplantation)
- •2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •3. Patients receiving a kidney from a non-heart beating donor
- •4. Patients who are recipients of A-B-O incompatible transplants
- •5. Patients with a current peak PRA of > 10%
- •6. Patients with already existing antibodies against the HLA-type of the receiving transplant
- •7. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine micro-emulsion, or other components of the formulations (e.g. lactose, see also SmPCs)
- •8. Use of other investigational drugs or a non-protocol immunosuppressant at randomization, or within 30 days or 5 half-lives prior to randomization, whichever is longer
- •9. 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
- •10. 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
- •11. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
- •12. Patients who are HIV positive or Hepatitis B surface antigen positive.
- •13. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •14. 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)
- •15. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double- barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation
- •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).
- •19. Patients with chronic bowel inflammatory disease.
研究者
相似试验
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic vs. a standard dosing regimen of Myfortic in combination with Neoral and Corticosteroids in de novo renal transplant patientsProphylaxis of the rejection after renal transplantMedDRA version: 14.1Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2006-003633-32-ITOVARTIS FARMA306
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patientsProphylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplantsEUCTR2006-003633-32-BEovartis Pharma Services AG306
进行中（未招募）
不适用
A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patientsProphylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplantsEUCTR2006-003633-32-SEovartis Pharma Services AG306
进行中（未招募）
1 期
A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupuslupus nephritis ( as part of the disease Systemic Lupus Erythematosus)EUCTR2005-003070-19-HUovartis Pharma Services AG
进行中（未招募）
不适用
Comparison of three different doses of PEG-rASNase and Oncaspar in treatment of adult patients with acute lymphoblastic leukaemiaAcute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood.MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-020613-91-DEmedac Gesellschaft für klinische Spezialpräparate mbH