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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00478608
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than or equal to 13 years of age.
2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%
Exclusion Criteria:
1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00478608
Study Brief:
Protocol Section:
NCT00478608