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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00007059
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant
Kidney transplant recipients will serve as study controls
--Prior/Concurrent Therapy--
* No concurrent bile acid sequestrants
* No mycophenolate mofetil as part of rescue therapy regimen
* No concurrent albumin replacement therapy
--Patient Characteristics--
Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL
Other:
* Not pregnant
* No mental incompetency
* No prisoners or parolees HIV negative
* No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00007059
Study Brief:
Protocol Section:
NCT00007059