Comparing Mizoribine and Mycophenolate Mofetil for Kidney Transplant Patients

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

This study is testing whether a new medication called Mizoribine is better than the standard treatment Mycophenolate Mofetil at preventing kidney transplant rejection in patients who have recently received a donor kidney.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lee's Pharmaceutical Limited (Industry-sponsored)
• Locations: 6 sites (Nanning, Guangxi and 5 other locations)
• Trial ID: NCT06114953 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized controlled study enrolling 152 adult patients who have recently undergone donor kidney transplantation across six clinical centers in China. Participants are randomly assigned to receive either Mizoribine or Mycophenolate Mofetil for a duration of 12 months, with follow-up assessments at various intervals to monitor clinical indicators, incidence of acute rejection, and overall kidney function. The study aims to evaluate the efficacy and safety of Mizoribine compared to the standard treatment with Mycophenolate Mofetil in preventing kidney transplant rejection.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients aged 18-75 who are first-time kidney transplant recipients.

Not a fit: Patients with multiple organ transplants, active infections, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective immunosuppressive treatment option for kidney transplant recipients, potentially improving transplant outcomes.

How similar studies have performed: While there have been studies on immunosuppressive therapies in kidney transplantation, this specific comparison of Mizoribine and Mycophenolate Mofetil is novel.

Eligibility 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.

Where this trial is running

Nanning, Guangxi and 5 other locations

• The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, China (Recruiting)

Study contacts

• Study coordinator: SHI JI HAN, Master

Conditions Kidney Transplant Immunosuppression; Immunosuppression; Kidney Transplant Rejection; mizoribine