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

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Mizoribine; Mycophenolic Acid

Criteria

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.