EUCTR2005-001518-42-ES进行中（未招募）不适用
A six-month, prospective, multicenter, open label, parallel, randomized study of the safety, tolerability and efficacy of myfortic® (ERL080) with Simulect®, corticosteroids and two different levels of tacrolimus in de novo renal transplant recipients
ovartis Farmaceútica S.A0 个研究点目标入组 288 人开始时间: 2005年6月29日最近更新:
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
- 288
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 patients between 18 and 70 years of age
- •2.Male or female patients who are primary cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
- •3.The renal cold ischemic time (CIT) must be <30 hours
- •4.The age of the donor must be between 10 and 65 years
- •5.The patient has given written informed consent to participate in the study
- •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
- •Patients meeting any of the following criteria at baseline will be excluded from study participation.
- •1.Patients who have previously received an organ transplant
- •2.Patients who are recipients of a multiple organ transplants
- •3.Recipients of non heart-beating donor organs
- •4.ABO incompatibility against the donor
- •5.Patients with panel reactive antibodies (PRA) of >20% at most recent assessment prior to transplantation
- •6.Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to first dose of myfortic® are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded
- •7.Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), or hemoglobin < 6g/dL prior to randomization.
- •8.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •10.Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
- •11.Patients with clinically significant systemic infection requiring continued therapy
- •12.Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin
- •13.Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to first dose of myfortic® which at investigators discretion would interfere with the objectives of the study
- •14.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test
- •15.Women of child-bearing potential (WOCBP), 16.Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse
- •17.Inability to cooperate or communicate with the investigator or unable to complete self administered GI symptoms questionnaires
研究者
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