NCT01601821已完成4 期
An Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids With Further CSA Elimination In The Rapamune Arm With The Introduction Of MMF
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Incidence of Efficacy Failure
研究概览
简要总结
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 years and weight 40 kg
- •End-stage renal disease, with patients receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
- •Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
- •Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x 10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
- •Signed and dated informed consent (parent or legal guardian must provide consent for patients <18 years of age). An assent form will be signed by patients < 18 years of age enrolled in the study.
排除标准
- •Evidence of active systemic or localized major infection at the time of initial Sirolimus administration.
- •Cadaveric donors
- •History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin)
- •Use of any investigational drug other than specified in the protocol during the 4 weeks before enrolling in the study.
- •Use of planned antibody induction therapy at the time of transplantation.
- •Active gastrointestinal disorder that may interfere with drug absorption.
- •Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.
- •Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
- •Patient with high risk of rejection (eg. Patients with a PRA >50%, black patients and patients with 2nd transplant who lost their first graft within the first 6 months).
- •Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
研究组 & 干预措施
Arm A (CsA+Rapamune+CS)
Active Comparator
干预措施: CsA+Rapamune+CS (Drug)
Arm B (CsA+MMF+CS)
Experimental
干预措施: CsA+MMF+CS (Drug)
结局指标
主要结局
Incidence of Efficacy Failure
时间窗: Baseline up to Month 12
Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.
次要结局
- Serum Creatinine Level(Month 3, 6, 12)
- Creatinine Clearance(Month 3, 6, 12)
- Glomerular Filtration Rate (GFR) by Nankivell Method(Month 3, 6, 12)
- Incidence of Biopsy-Confirmed Acute Rejection(Baseline up to Month 6)
- Histologic Grade of First Acute Rejection(Baseline up to Month 12)
- Percentage of Participants Who Survived(Month 12)
- Percentage of Participants With Graft Survival(Month 12)
- Incidence of Presumptive or Documented Infection(Baseline up to Month 12)
- Incidence of Histologically Confirmed Lymphoproliferative Disease(Baseline up to Month 12)
- Percentage of Participants With Efficacy Failure or Premature Elimination(Month 12)
- Incidence of Anemia(Baseline up to Month 12)
- Number of Participants Who Discontinued(Month 12)
研究者
研究点 (4)
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