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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT00817206
Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 18 years of age who are recipients of a kidney transplant between 3 months and 5 years before the screening date
* Patients taking oral Prograf® capsules twice daily, at least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 5 to 15 ng/mL
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug
Exclusion Criteria:
* Recipients of any transplanted organ other than kidney
* Recipients of a bone marrow transplant
* Patients with an eGFR (MDRD7) \< 30 mL/min at Screening
* Patients with a spot protein:creatinine ratio \> 0.5
* Patients with a WBC count ≤ 2.8 ´ 109/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is \> 1.0 ´ 109 /L
* Patients unable to swallow study medication
* Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with the study protocol requirements
* Pregnant or nursing women
* Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
* Patients who were treated with any other investigational agent within 3 months before Screening
* Patients who have taken sirolimus or everolimus within 3 months before Screening
* Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed-release tablets (Myfortic) who have not been on stable doses for at least 4 weeks before Screening
* Patients withdrawn from corticosteroids less than 30 days before Screening
* Patients with an episode of acute rejection requiring antibody therapy within 3 months before Screening
* Patients treated for acute rejection within 30 days before Screening
* Patients who are hepatitis C virus (HCV) negative who have received an HCV positive (HCV RNA by polymerase chain reaction or HCV antibody) donor kidney
* Patients seropositive for human immunodeficiency virus
* Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or nonmetastatic squamous cell carcinoma of the skin that has been treated successfully
* Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
* Patients with severe diarrhea, vomiting, active peptic ulcer, or gastrointestinal disorder that may affect the absorption of tacrolimus
* Patients with any form of current substance abuse, psychiatric disorder, or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00817206
Study Brief:
Protocol Section:
NCT00817206