NCT00895206已完成4 期
Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
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
- 128
- 试验地点
- 1
- 主要终点
- Graft function as measured by Cr EDTA AUC
研究概览
简要总结
This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second kidney transplantation
- •Males and females, 18 years old or older
- •Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/mL
- •Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form
排除标准
- •Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
- •Transplantation of a patient who received another organ transplant previously except one kidney transplant
- •Recipients of HLA-identical living-related renal transplants
- •Patients with PRA > 10%, patients who have lost a first graft from rejection.
- •Pregnant or lactating women
- •WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6g/dl at the time of entry into the study
- •Active peptic ulcer
- •Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
- •Known HIV-1 or HTLV-1 positive tests
- •History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
- •The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
- •Patients receiving bile acid sequestrants
- •Psychological illness or condition interfering with the patient's compliance or ability to understand the requirements of the study.
研究组 & 干预措施
1
Experimental
individual adapted immunosuppression
干预措施: individual adapted immunosuppression (Drug)
2
Active Comparator
golden standard therapy
干预措施: golden standard therapy (Drug)
结局指标
主要结局
Graft function as measured by Cr EDTA AUC
时间窗: at 1 year
次要结局
- Development and evolution of glucose abnormalities(at 1 year)
- blood pressure(at 1 year)
- ambulatory 24-hr blood pressure monitoring(at 1 year and 3 years)
- Left ventricular mass assessed by echocardiography(at 1 year and 3 years)
- Fasting lipid profile(at baseline, month 1,3,6 and yearly)
- CMV infection (as measured with whole blood PCR) and disease(at 1 year)
- Polyoma virus replication as measured by whole blood PCR(at 1 year)
- Incidence of BK nephritis(in month 3 and month 12 biopsies)
- Proteinuria(at month 1, 3 and at 1 and 3 years)
- Incidence of PTLD and Nonmelanoma skin cancer(at 1 year and yearly)
- Incidence of EBV reactivation (as measured with whole blood PCR)(at 1 year and yearly)
- Graft survival(at 1 year)
- Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)(at 1 year)
- Frequency of biopsy proven acute rejection episodes(at 1 year)
- Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).(at 1 year)
- Time to first rejection (days)(at 1 year)
- Severity of rejection as assessed by BANFF 2005 score(at 1 year)
- Number of acute rejections per patient(at 1 year)
- Plasma creatinine and eGFR(at month 1, 3 and yearly (2 and 3 years))
- Measured GFR(at month 3 and yearly)
- Incidence and score of borderline changes and acute rejection(in month 3 and month 12 biopsy)
- Incidence and score of chronic alloimmune injury/rejection and nonimmune injury(in month 3 and month 12 biopsies (BANFF 2005))
- Patient survival(at 1 year)
- Incidence of rejection treated by antibodies (OKT3, ATG)(at 1 year)
研究者
研究点 (1)
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