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

Lee's Pharmaceutical

Status and phase: Enrolling; Phase 4

Conditions: Kidney Transplant Immunosuppression

Treatments: Drug: Mizoribine; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06114953

BRDN-LEES-2023-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Mizoribine group

Experimental group

Description:

Mizoribine, glucocorticoid, tacrolimus

Treatment:

Drug: Mizoribine

Mycophenolate group

Active Comparator group

Description:

Mycophenolate mofetil, glucocorticoid, tacrolimus

Treatment:

Drug: Mycophenolate Mofetil