Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 Investigators at participating centers will identify patients fulfilling inclusion criteria and do not violate any exclusion criteria. Informed consent will be obtained upon entry into the study according to national regulations. Patients will be enrolled into the study and clinical data of patient history will be collected. Clinical data will be collected prospectively up to a total period of 12 months.

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

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Mycophenolic Acid

Criteria

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.