Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
NCT ID: NCT06114953
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
152 participants
INTERVENTIONAL
2023-01-01
2025-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mizoribine group
Mizoribine, glucocorticoid, tacrolimus
Mizoribine
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
Mycophenolate group
Mycophenolate mofetil, glucocorticoid, tacrolimus
Mycophenolate Mofetil
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
Interventions
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Mizoribine
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
Mycophenolate Mofetil
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\) Adult recipients aged 18-75 years, regardless of gender;
* 3\) First-time kidney transplant recipients;
* 4\) Voluntarily sign written informed consent.
Exclusion Criteria
* 2\) DSA positive patients had ABO incompatibility and PRA\>30%;
* 3\) Recipients with active signs of infection;
* 4\) Recipients with leukocyte counts below 3,000/mm3;
* 5\) Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
* 6\) Patients with severe gastrointestinal diseases and active peptic ulcer disease;
* 7\) suffering from any mental illness;
* 8\) Patients with severe heart disease and abnormal heart function;
* 9\) Subjects who are known to be allergic to the test drug;
* 10\) Recipients judged unsuitable for inclusion by other competent physicians.
18 Years
75 Years
ALL
No
Sponsors
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Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Principal Investigators
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TAO LIN, Doctor
Role: STUDY_CHAIR
West China Hospital
Locations
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The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
West China Hospital, Sichuan University
Chengdu, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Shi Y, Liu H, Chen XG, Shen ZY. Efficacy and Safety of Mizoribine Combined With Tacrolimus in Living Donor Kidney Transplant Recipients: 3-Year Results by a Chinese Single Center Study. Transplant Proc. 2019 Jun;51(5):1337-1342. doi: 10.1016/j.transproceed.2019.03.014.
Ju MK, Huh KH, Park KT, Kim SJ, Cho BH, Kim CD, So BJ, Kang CM, Lee S, Joo DJ, Kim YS. Mizoribine versus mycophenolate mofetil in combination therapy with tacrolimus for de novo kidney transplantation: evaluation of efficacy and safety. Transplant Proc. 2013 May;45(4):1481-6. doi: 10.1016/j.transproceed.2012.12.028.
Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
Other Identifiers
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BRDN-LEES-2023-10
Identifier Type: -
Identifier Source: org_study_id
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