EUCTR2005-002854-22-GB进行中（未招募）1 期
A 24-month, multicenter, randomized, open-label non-inferiority study of efficacy and safety comparing concentration-controlled Certican® in two doses (1.5 and 3.0 mg/day starting doses) with reduced Neoral® versus 1.44 g Myfortic ® with standard dose Neoral® in de novo renal transplant recipients -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating
- •Patients who have 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 with no evidence of graft funtion within 24 hours of transplantation are excluded.
- •Cold ischemia time >40 hours, non-heartbeating donor , donor age >65
- •Patients with platelet count <100,000/mm at the evaluation before randomization.
- •Patients with an absolute neutrophil count of < 1,500/mm³ at baseline before surgery or white blood cell count of < 4,500/mm³
- •Patients who are recipients of multiple solid organ or tissue transplants, or who previously received an organ or tissue transplant
- •Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
- •Patients who have an abnormal liver profile such as ALT, AST, Alk Phos or total bilirubin >3 times the ULN
- •Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
- •Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole or cisapride
- •Patients who are unable to take oral medication at time of randomization.
- •Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
- •Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised basal cell carcinoma of the skin
- •Patients with most recent anti-HLA Class I Panel Reactive Antibodies >20% by a CDC- (Complement dependent cytotoxicity) based assay or >50% by a Flow Cytometry or ELISA (Enzyme linked Immunosorbent assay)- based assay, recipients of ABO incompatible transplants or T cell crossmatch positive transplant.
- •Patients who have tested positive for HIV, Hepatitis C or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within one week of randomization.
- •Patients with clinically significant systemic infection at time of transplant or within two weeks of transplant.
- •Recipients of Kidneys from HLA- identical living related donors
- •Recipients of dual kidney transplants
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen, Hepatitis C or HIV are excluded
- •Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
- •Patients who have cardiac failure at time of screening (resting dyspnea, less than or equal to Grade 3 according to Old New York Heart Association Classification (Appendix 8) or any severe cardiac disease as determined by the investigator.
- •Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication.
- •Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the
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