EUCTR2005-002854-22-SK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
- 性别
- All
入选标准
- •Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating
- •Recipients of primary cadaveric, living unrelated or non HLA identical living related donor
- •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
- •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 transplants, or who previously received an organ 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 who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole, cisapride or lovastatin
- •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 basal cell carcinoma of the skin
- •Patients with current Panel Reactive Antibodies >20%, recipients of ABO incompatible transplants or T cell crossmatch positive transplant.
- •Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive.
- •Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded
- •Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
- •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, and/or the presence of severe diarrhea or active peptic ulcer
- •Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study
- •Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation after transplantation. (Low dose aspirin treatment is allowed)
研究者
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