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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00579592
Eligibility Criteria:
Inclusion Criteria:
* Recipient of cadaver or non HLA identical living donor transplantation (tx), Re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p)
* Females of CBP must have neg preg test at the time of study enrollment (SOC) \& agree to practice birth control for duration of the study, or for 6 weeks after the last dose of Myfortic
Exclusion Criteria:
* Subjects who are pregnant or nursing.
* Current malignancy or a malignancy in the past 5 years, except for excised skin CA (BCC or SC)
* Multi-organ tx, ABO incompatible and + CM
* Subjects with a current PRA \>50% within the past 30 days pre tx
* Subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis B (surface antigen +) or +HCV.
* Exclude for subjects who have received an investigational drug within 4 weeks of study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00579592
Study Brief:
Protocol Section:
NCT00579592