Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
1 other identifier
interventional
152
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2023
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedNovember 2, 2023
October 1, 2023
2 years
October 24, 2023
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum creatinine
Monitoring serum creatinine.
Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Other Outcomes (4)
White blood cell
Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Cytomegalovirus DNA copies.
Postoperative 3，6，12 months.
BK Virus DNA copies.
Postoperative 3，6，12 months.
- +1 more other outcomes
Study Arms (2)
Mizoribine group
EXPERIMENTALMizoribine, glucocorticoid, tacrolimus
Mycophenolate group
ACTIVE COMPARATORMycophenolate mofetil, glucocorticoid, tacrolimus
Interventions
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
Eligibility Criteria
You may qualify if:
- \) After donor kidney transplantation;
- \) Adult recipients aged 18-75 years, regardless of gender;
- \) First-time kidney transplant recipients;
- \) Voluntarily sign written informed consent.
You may not qualify if:
- \) 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Related Publications (4)
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.
PMID: 31155174RESULTJu 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.
PMID: 23726602RESULTHuh 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.
PMID: 28810721RESULTWajih 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.
PMID: 39382091DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
TAO LIN, Doctor
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
November 2, 2023
Study Start
January 1, 2023
Primary Completion
January 1, 2025
Study Completion
March 1, 2025
Last Updated
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
No IPD shared plan.