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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT02496494
Eligibility Criteria:
Inclusion Criteria:
1. Patients who received a kidney transplant at least 12 months ago prior to enrollment
2. Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.
3. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial
4. Patients who are considered clinically stable by observer's judgment.
5. Patients must understand the purpose and risk of participating the the trial and signed on the written consent.
Exclusion Criteria:
1. Patients who have previously received an organ transplant other than a kidney
2. Patients diagnosed with congestive heart failure within 6 months (EF \<35%)
3. Patients with untreated ischemic heart disease
4. Patients whose hemoglobin is in the level of \<7.0 g/dL
5. Patients who have a known hypersensitivity to tacrolimus
6. Patients taking potassium sparing diuretics
7. Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted
8. Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer
9. Patients who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02496494
Study Brief:
Protocol Section:
NCT02496494