Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Serum creatinine
研究概览
简要总结
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.
详细描述
This is a multi-center, prospective, non-inferior, randomized controlled clinical study. The sick individuals and their families participating in the trial voluntarily participate and sign the "informed consent" under the premise of fully understanding the treatment plan; The treatment plan was approved by the hospital ethics committee.
A total of 152 patients from six centers nationwide will be enrolled starting from the date when the center's ethics are officially approved. The qualified recipients of donor kidney transplantation were randomly assigned 1:1 to the control group and the experimental group. The control group was treated with glucocorticoid + MPA+ tacrolimus for 12 months, and the experimental group was treated with glucocorticoid +MZR+ tacrolimus for 12 months. All subjects were followed up on the day of renal transplantation, at 1, 2 weeks and 1, 2, 3, 6, 9 and 12 months after the operation: history collection, incidence of acute rejection, survival rate of recipients, survival rate of transplanted kidney, liver and kidney function, blood routine and urine routine; Cytomegalovirus (CMV)-DNA and BK virus (BKV)-DNA copy levels were detected in blood at 1, 3, 6, 9, and 12 months after renal transplantation to assess CMV and BKV infection. Adverse reactions were recorded during follow-up.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After donor kidney transplantation;
- •Adult recipients aged 18-75 years, regardless of gender;
- •First-time kidney transplant recipients;
- •Voluntarily sign written informed consent.
排除标准
- •Multiple organ transplantation;
- •DSA positive patients had ABO incompatibility and PRA>30%;
- •Recipients with active signs of infection;
- •Recipients with leukocyte counts below 3,000/mm3;
- •Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
- •Patients with severe gastrointestinal diseases and active peptic ulcer disease;
- •suffering from any mental illness;
- •Patients with severe heart disease and abnormal heart function;
- •Subjects who are known to be allergic to the test drug;
- •Recipients judged unsuitable for inclusion by other competent physicians.
研究组 & 干预措施
Mizoribine group
Mizoribine, glucocorticoid, tacrolimus
干预措施: Mizoribine (Drug)
Mycophenolate group
Mycophenolate mofetil, glucocorticoid, tacrolimus
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Serum creatinine
时间窗: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Monitoring serum creatinine.
次要结局
未报告次要终点