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

Last updated: October 30, 2023
Sponsor: Lee's Pharmaceutical Limited
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Mycophenolate Mofetil

Mizoribine

Clinical Study ID

NCT06114953
BRDN-LEES-2023-10
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

    1. Multiple organ transplantation;
    1. DSA positive patients had ABO incompatibility and PRA>30%;
    1. Recipients with active signs of infection;
    1. Recipients with leukocyte counts below 3,000/mm3;
    1. Pregnant women, breastfeeding women or women who do not wish to use appropriatecontraceptive methods during the study period;
    1. Patients with severe gastrointestinal diseases and active peptic ulcer disease;
    1. suffering from any mental illness;
    1. Patients with severe heart disease and abnormal heart function;
    1. Subjects who are known to be allergic to the test drug;
    1. Recipients judged unsuitable for inclusion by other competent physicians.

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: Mycophenolate Mofetil
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu,
    China

    Active - Recruiting

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