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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mizoribine group | Experimental | Mizoribine, glucocorticoid, tacrolimus |
|
| Mycophenolate group | Active Comparator | Mycophenolate mofetil, glucocorticoid, tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mizoribine | Drug | Mizoribine+glucocorticoid+tacrolimus after kidney transplantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | Monitoring serum creatinine. | Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| White blood cell | Detect the count of white blood cell. | Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months. |
| Cytomegalovirus DNA copies. | Detect Cytomegalovirus DNA copies in blood. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHI JI HAN, Master | Contact | 13929517813 | shiji.han@leespharm.com |
| Name | Affiliation | Role |
|---|---|---|
| TAO LIN, Doctor | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31155174 | Result | 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. | |
| 23726602 | Result | 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. |
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No IPD shared plan.
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Experimental group: glucocorticoid, mizoribine, tacrolimus; Control group: glucocorticoid, mycophenolate mofetil.
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| Mycophenolate Mofetil |
| Drug |
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation |
|
|
| Postoperative 3,6,12 months. |
| BK Virus DNA copies. | Detect BK virus DNA copies in blood and urine. | Postoperative 3,6,12 months. |
| Uric Acid | Check uric acid levels. | Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months. |
| Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | China |
|
| First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | China |
|
| 28810721 | Result | 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. |
| 39382091 | Derived | 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. |
| ID | Term |
|---|---|
| C010052 | mizoribine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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