A Multicenter Clinical Trial: Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the incidence of Donor specific antibody(DSA) formation during 12-months post-transplantation
研究概览
简要总结
THE INCIDENCE AND INFLUENTIAL FACTORS OF DSA IN CHINESE RENAL TRANSPLANT RECIPIENTS WITH MPA-BASED IMMUNOSUPPRESSIVE REGIMEN： A MULTI-CENTER CLINICAL STUDY (TIAIFOD STUDY)
Study procedure Investigators at participating centers will identify patients fulfilling inclusion criteria and do not violate any exclusion criteria. Informed consent will be obtained upon entry into the study according to national regulations. Patients will be enrolled into the study and clinical data of patient history will be collected. Clinical data will be collected prospectively up to a total period of 12 months.
详细描述
Medical history and Kidney transplantation This will include age at transplantation, gender, race, weight, height of both recipient and donor; Recipients: previous history ,BMI ,primary kidney disease including biopsy proven diagnosis (if present), historic dialysis，pregnancy history (female). Donor: the catalogue (DCD,DBD,DBCD), ECD or not，the cause of death, received CPR or not; zero biopsy results if done, ABO blood type match, HLA-MM, cold and warm ischemic time.
Clinical data at baseline and 12months follow up period:
Clinical assessments, laboratory, comorbidity, immunosuppressive therapy, and selected concomitant therapy (anti-hypertension anti-hyperlipidemics, anti-diabetics and drugs known to affect renal function) will be collected at transplant day（Day 0, visit 0）and 8 subsequent visits scheduled Day 3, Week1, Week2, Week 4，Week 12，Week 26，Week 40，Week 52 post transplantation. MPA-AUC, acute rejection episodes and graft loss will be collected at visits scheduled Day 3, Week 1，Week 2, Week 4，Week 12， Week 26(6 month)，Week 40，Week 52 (12 month) post transplantation. On day 3, MPA-AUC will be tested by full time sample (0h,0.5h,1h,2h,3h,4h,6h,8h,10h,12h post receiving MMF). LSS (0h, 0.5h, 2h post receiving MMF) will be used for testing MPA-AUC on other visits. PRA will be tested on week 4, week 12, week 26, week 52. If PRA is positive, DSA will be tested following once. All the PRA and DSA MFI and phenotype will be collected（including the clinical-drive test）.
Statistical analysis:
The primary endpoint in this study is the incidence of DSA formation in 12-months post-transplantation in Chinese kidney transplant recipients with MMF-based IS regimen. The proportion and its 95% CI will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female kidney transplant recipients from 18 to 65 years of age (including 18 & 65 years old patients)
- •Single organ and first kidney transplant recipients from donation after citizen's death
- •Patients who received MMF+TAC+ Corticosteroids immunosuppressive regimen as first choice post transplantation
- •Pre-transplant PRA is negative (0%)
- •One serum pregnancy test with a sensitivity of at least 25mlU/Ml for patients of childbearing potential before enrolled. A second test should be performed 8-10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient. Patients should be instructed to consult their physician immediately should pregnancy occur. For patients to be included in the study, negative result must be obtained. And highly effective contraception for women of childbearing potential. Contraception must be taken before beginning study drug therapy, during therapy and for 6 weeks after the last dose of study medication
- •Exclusion criteria:
- •Patients who do not receive MMF
- •Patients who are re-transplantation or multiple organ transplantation recipients
- •Female patients who are pregnant or lactating
- •Patients who have any form of substance abuse, psychological illness or any other condition, which, in the opinion of the investigator, may interfere with the patient's ability to understand the requirements of the study.
- •Patients who would have received another investigational drug within 30 days preceding the enrollment, received prohibited immunosuppressant medications prior to transplant
- •Patients who are using AZA, MTX, CTX or will use these drugs post-transplantation
- •Known contraindications to TAC , corticosteroids, MMF
- •Patients who have active peptic ulcer
- •Patients who have severe cardiac or lung disease
- •Patient who have active hepatica disease
- •Patients who have a history of cancer, except successfully treated localized nonmelanocytic skin cancer
- •Patients who would not be available for routine study visits or follow-up, or not being followed by an accredited laboratory.
排除标准
- 未提供
研究组 & 干预措施
Mycophenolate Mofetil Capsules
The dosage of mycophenolate mofetil (CellCept) will be decided by the investigator and should be adjusted according to clinical response or therapeutic drug monitoring. It is not allowed to switch to other MPAs. When MMF is discontinued but is not switched to other MPA, the patients will be followed until the end of study.
干预措施: Mycophenolate Mofetil Capsules (Drug)
结局指标
主要结局
the incidence of Donor specific antibody(DSA) formation during 12-months post-transplantation
时间窗: 12-months
the incidence of DSA formation during 12-months post-transplantation
次要结局
- the incidence of DSA formation during 6-months post-transplantation(6 months)
- the influential factors of DSA formation(12 months)
- the association between DSA and MPA AUC(12 months)
- the proportion of patients experiencing Acute Rejection(AR), Biopsy proven acute rejection(BPAR), Antibody mediated rejection(ABMR) and the association with Donor specific antibody(DSA)(12 months)
- the renal function (Calculated creatinine clearance) at 12 month and association with DSA(12 months)
- the calculation formula for MPA-AUC with ISS using multiple regression analysis(12 months)
- the death-censored graft survival rate at 12 month post transplantation and association with Donor specific antibody(DSA)(12 months)