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

October 30, 2023 updated by: Lee's Pharmaceutical Limited
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
      • Chengdu, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mizoribine group
Mizoribine, glucocorticoid, tacrolimus
Drug: Mizoribine
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
Active Comparator: Mycophenolate group
Mycophenolate mofetil, glucocorticoid, tacrolimus
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
Other Names:
  • Mycophenolate Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinine
Time Frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Monitoring serum creatinine.
Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
White blood cell
Time Frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Detect the count of white blood cell.
Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Cytomegalovirus DNA copies.
Time Frame: Postoperative 3，6，12 months.
Detect Cytomegalovirus DNA copies in blood.
Postoperative 3，6，12 months.
BK Virus DNA copies.
Time Frame: Postoperative 3，6，12 months.
Detect BK virus DNA copies in blood and urine.
Postoperative 3，6，12 months.
Uric Acid
Time Frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Check uric acid levels.
Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Investigators

  • Study Chair: TAO LIN, Doctor, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRDN-LEES-2023-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD shared plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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