Status:
UNKNOWN
Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Kidney Transplant Recipients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
THE INCIDENCE AND INFLUENTIAL FACTORS OF DSA IN CHINESE RENAL TRANSPLANT RECIPIENTS WITH MPA-BASED IMMUNOSUPPRESSIVE REGIMEN： A MULTI-CENTER CLINICAL STUDY (TIAIFOD STUDY) Study procedure Investigato...
Detailed Description
Medical history and Kidney transplantation This will include age at transplantation, gender, race, weight, height of both recipient and donor; Recipients: previous history ,BMI ,primary kidney disease...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female kidney transplant recipients from 18 to 65 years of age (including 18 \& 65 years old patients)
- Single organ and first kidney transplant recipients from donation after citizen's death
- Patients who received MMF+TAC+ Corticosteroids immunosuppressive regimen as first choice post transplantation
- Pre-transplant PRA is negative (0%)
- One serum pregnancy test with a sensitivity of at least 25mlU/Ml for patients of childbearing potential before enrolled. A second test should be performed 8-10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient. Patients should be instructed to consult their physician immediately should pregnancy occur. For patients to be included in the study, negative result must be obtained. And highly effective contraception for women of childbearing potential. Contraception must be taken before beginning study drug therapy, during therapy and for 6 weeks after the last dose of study medication
- Exclusion criteria:
- Patients who do not receive MMF
- Patients who are re-transplantation or multiple organ transplantation recipients
- Female patients who are pregnant or lactating
- Patients who have any form of substance abuse, psychological illness or any other condition, which, in the opinion of the investigator, may interfere with the patient's ability to understand the requirements of the study.
- Patients who would have received another investigational drug within 30 days preceding the enrollment, received prohibited immunosuppressant medications prior to transplant
- Patients who are using AZA, MTX, CTX or will use these drugs post-transplantation
- Known contraindications to TAC , corticosteroids, MMF
- Patients who have active peptic ulcer
- Patients who have severe cardiac or lung disease
- Patient who have active hepatica disease
- Patients who have a history of cancer, except successfully treated localized nonmelanocytic skin cancer
- Patients who would not be available for routine study visits or follow-up, or not being followed by an accredited laboratory.
Exclusion
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04444843
Start Date
January 22 2021
End Date
December 31 2023
Last Update
May 27 2022
Active Locations (1)
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1
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000