Clinical trial NCT06114953: Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
Official title: Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Kidney Transplant Immunosuppression
Keywords: Immunosuppression
Kidney Transplant Rejection
mizoribine
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: glucocorticoid, mizoribine, tacrolimus; Control group: glucocorticoid, mycophenolate mofetil.
Primary purpose: TREATMENT

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 follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 1) After donor kidney transplantation;
* 2) Adult recipients aged 18-75 years, regardless of gender;
* 3) First-time kidney transplant recipients;
* 4) Voluntarily sign written informed consent.

Exclusion Criteria:

* 1) Multiple organ transplantation;
* 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.

Primary outcomes:
measure: Serum creatinine
timeFrame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Secondary outcomes:
Other outcomes:
measure: White blood cell
timeFrame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
measure: Cytomegalovirus DNA copies.
timeFrame: Postoperative 3，6，12 months.
measure: BK Virus DNA copies.
timeFrame: Postoperative 3，6，12 months.
measure: Uric Acid
timeFrame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Locations:
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
Study officials:
affiliation: West China Hospital
name: TAO LIN, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.