NCT01680952已完成4 期
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 7
- 主要终点
- Failure rate in effectiveness of up to 12 months after kidney transplant
研究概览
简要总结
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged over 20 years
- •Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
- •Patients has given written informed consent
- •Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
- •Patients has received an ABO compatible donor kidney.
- •Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization
排除标准
- •Patient has previously received an organ transplant other than a kidney.
- •Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
- •Desensitization
- •HLA-identical
- •Heart Disease; Heart failure (symptom, EF <45%)
- •Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
- •Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
- •malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
- •Patient has received a kidney transplant from non-heart beating donor
- •Cold ischemic time > 30hrs
- •Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
- •(ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3
- •ATG: Anti-thymocyte globulin induction
- •Medical condition that could interfere with the study objectives.
- •Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
- •Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
- •Patient who is judged not to be adequate by the investigator owing to other reasons
- •Patient is pregnant or lactating.
- •Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)
研究组 & 干预措施
A) TEST
Active Comparator
干预措施: A) TEST (Drug)
A) TEST
Active Comparator
干预措施: B) CONTROL (Drug)
B) CONTROL
Experimental
干预措施: A) TEST (Drug)
B) CONTROL
Experimental
干预措施: B) CONTROL (Drug)
结局指标
主要结局
Failure rate in effectiveness of up to 12 months after kidney transplant
时间窗: 12 months after kidney transplant
1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.
次要结局
未报告次要终点
研究者
研究点 (7)
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