NCT00681213已完成4 期
Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants
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
- 150
- 试验地点
- 1
- 主要终点
- Incidence and severity of acute rejection episodes
研究概览
简要总结
Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >14 years
- •Weight > 40 kg
- •Primary renal allograft: cadaveric or mismatched living donor
- •Negative standard cross match for T-cells
- •Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
- •Signed and dated informed consent (Parent or legal guardian must provide written consent for patients <18 years of age)
排除标准
- •Evidence of systemic infection
- •History of malignancy within 10 years (with the exception of localized skin cancer)
- •Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
- •Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
- •Known hypersensitivity to sirolimus and its derivatives
- •Patients with a screening/baseline (or within 96 hours of transplant)
- •total white blood cell count < 4000/mm3;
- •platelet count < 100,000/mm3;
- •fasting triglycerides > 400 mg/dl (> 4.6 mmol/L);
- •fasting total cholesterol > 300 mg/dl (> 7.8 mmol/L);
- •fasting HDL-cholesterol < 30 mg/dl;
- •fasting LDL-cholesterol > 200mg/dl
研究组 & 干预措施
A
Experimental
Tacrolimus/Sirolimus
干预措施: Tacrolimus/Sirolimus (Drug)
B
Experimental
Tacrolimus/MMF
干预措施: Tacrolimus/MMF (Drug)
C
Experimental
Neoral/Sirolimus
干预措施: Neoral/Sirolimus (Drug)
结局指标
主要结局
Incidence and severity of acute rejection episodes
时间窗: 1 year
次要结局
- 1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months(1, 3, and 5 years)
研究者
研究点 (1)
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