Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients

Kidney Transplant Immunosuppression Clinical Trial

Official title:

Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114953
• Other study ID #: BRDN-LEES-2023-10
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Lee's Pharmaceutical Limited
• Contact: SHI JI HAN, Master
• Phone: 13929517813
• Email: shiji.han[@]leespharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Immunosuppression

Intervention

Drug:
• Mizoribine
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
• Mycophenolate Mofetil
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

References & Publications (3)

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, — View 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. 2 — View 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.transprocee — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	White blood cell	Detect the count of white blood cell.	Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months.
Other	Cytomegalovirus DNA copies.	Detect Cytomegalovirus DNA copies in blood.	Postoperative 3,6,12 months.
Other	BK Virus DNA copies.	Detect BK virus DNA copies in blood and urine.	Postoperative 3,6,12 months.
Other	Uric Acid	Check uric acid levels.	Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months.
Primary	Serum creatinine	Monitoring serum creatinine.	Postoperative 1 week, 2 weeks, 1month, 2,3,6,9,12 months