Status:
UNKNOWN
Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Kidney Transplant Immunosuppression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 2...
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 "inform...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06114953
Start Date
January 1 2023
End Date
March 1 2025
Last Update
November 2 2023
Active Locations (6)
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1
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
2
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
3
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
4
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China