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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05293704
Eligibility Criteria:
Inclusion Criteria:
* Kidney transplant recipients;
* Postoperative maintenance therapy with glucocorticoid + tacrolimus +MPA;
* Urinary BKV-DNA load ≥10\^7/L;
* No gender limitation for recipients \> 18 years of age;
* Voluntarily sign written informed consent.
Exclusion Criteria:
* Multiple organ transplantation;
* Acute rejection occurred within 1 week before enrollment;
* Recipients with signs of active infection;
* Recipients with white blood cell count below 3,000 /cubic metre;
* Women who are pregnant, breast-feeding, or unwilling to use appropriate contraceptive methods during the study period;
* Patients with serious gastrointestinal diseases and active peptic ulcer disease;
* Suffering from any mental illness;
* Patients with severe heart disease and abnormal cardiac function;
* Subjects with known allergy to the test drug;
* Other competent physicians judged that the recipients were not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05293704
Study Brief:
Protocol Section:
NCT05293704