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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT04224350
Eligibility Criteria:
Inclusion Criteria:
* Over 20 years old(male or female)
* Patients with eGFR (By CKD-EPI) ≥30mL/min/1.73m\^2 and spot urine P/C ratio≤0.5 at screening test
* Patients who are taking Tacrolimus twice a day for maintenance therapy and have Trough level of 3\~10ng/ml
* Agreement with written informed consent
Exclusion Criteria:
* Patients who have transplanted organs other than kidney
* Patients with acute rejection who have been clinically treated within the last month
* Patients who have changed their administration of adjuvant immunosuppressants and corticosteroids within the last month (dose change, discontinuation, etc.)
* Patients who have been diagnosed with cancer within the last 5 years (except skin cancer or thyroid cancer determined by the investigator that treatment has been completed)
* Patients deemed inappropriate for screening due to severe digestive disorders at screening
* Patients with severe systemic infections requiring treatment (transplantation may be possible after the infection is completely lost or controlled)
* Patients with genetic problems of galactose-intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* If the following cases occur during screening
* Treatment of active liver disease or increased one or more of the liver function tests (T-bilirubin, AST, ALT) levels more than three times the upper limit of normal range
* Patients with WBC \<2,500/mm\^3, PLT \<75,000/mm\^3, ANC \<1,300/μL
* Patients who have experienced hypersensitivity reactions or serious abnormalities with medicines used in this clinical trial or with similar chemical structures (Tacrolimus, etc.)
* Pregnant or lactating women
* Patients of childbearing potential who do not agree to the proper use of contraception during the trial
* Patients who received other investigational drugs within 4 weeks prior to consent of the document
* Patients unable to participate in the clinical trial due to the judgment of other investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04224350
Study Brief:
Protocol Section:
NCT04224350