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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01387659
Eligibility Criteria:
Inclusion Criteria:
1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
2. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
3. Written inform consent obtained. The patients are willing to participate in the study at UTMB.
4. Female with negative pregnancy test.
5. PRA \< 20 %.
6. En-blocks and two kidneys (tx'd at the same time) will be allowed.
7. Cold Ischemia time ≤ 30 hrs
8. Hep C patients will be allowed to enroll in this study
Exclusion Criteria:
1. Multi-organ transplants
2. Transplant from non-heart beating donor (NHBD) or dual transplants
3. A-B-O incompatible or positive cross match
4. Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
5. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
6. Inability to tolerate oral medications
7. Inability to sign a written consent form or to cooperate with investigators
8. Use of an investigational medication in the past 30 days.
9. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
10. HIV positive patients
11. History of psychosocial instability
12. Mental incompetence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01387659
Study Brief:
Protocol Section:
NCT01387659