Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT05872568
Eligibility Criteria:
Inclusion Criteria:
1. Male and female, aged 18-65;
2. Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
3. After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
4. The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.
Exclusion Criteria:
1. Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
2. ABO incompatible kidney transplant recipients;
3. HLA antibodies or past/current population reactive antibody level (PRA) \> 25% were preexisting in the recipient before renal transplantation;
4. Allergic to EC-MPS or preparation components (hypersensitivity);
5. Women with fertility potential who are pregnant, lactating or planning to become pregnant;
6. Severe/uncontrolled concomitant infections or other serious medical problems;
7. Active bacterial, viral or fungal infections;
8. Neutropenia (ANC\<1.3×103/µL)
9. Patients judged by the investigator to be unsuitable for inclusion in this study for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05872568
Study Brief:
Protocol Section:
NCT05872568