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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02963103
Eligibility Criteria:
Inclusion Criteria:
* Patients received a kidney transplant at least 12 months before enrollment.
* Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
* Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
* Serum creatinine \< 2.3 mg/dl at enrollment
* Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
* Patients considered clinically stable
Exclusion Criteria:
* Patients who have previously received an organ transplant other than a kidney.
* Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
* Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
* Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
* Proteinuria \> 2 g/24 hrs.
* Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
* Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
* Patients who have liver cirrhosis.
* Patients who are pregnant or breastfeeding.
* Patients who had been HIV-positive.
* Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
* Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
* Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
* Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.
* Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02963103
Study Brief:
Protocol Section:
NCT02963103