Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
- Conditions
- Interventions
- Registration Number
- NCT06114953
- Lead Sponsor
- Lee's Pharmaceutical Limited
- Brief Summary
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 foll...
- Detailed Description
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.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 152
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- After donor kidney transplantation;
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- Adult recipients aged 18-75 years, regardless of gender;
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- First-time kidney transplant recipients;
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- Voluntarily sign written informed consent.
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- Multiple organ transplantation;
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- DSA positive patients had ABO incompatibility and PRA>30%;
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- Recipients with active signs of infection;
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- Recipients with leukocyte counts below 3,000/mm3;
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- Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
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- Patients with severe gastrointestinal diseases and active peptic ulcer disease;
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- suffering from any mental illness;
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- Patients with severe heart disease and abnormal heart function;
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- Subjects who are known to be allergic to the test drug;
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- Recipients judged unsuitable for inclusion by other competent physicians.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mizoribine group Mizoribine Mizoribine, glucocorticoid, tacrolimus Mycophenolate group Mycophenolate Mofetil Mycophenolate mofetil, glucocorticoid, tacrolimus
- Primary Outcome Measures
Name Time Method Serum creatinine Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months Monitoring serum creatinine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China