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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01294020
Eligibility Criteria:
Inclusion Criteria:
* Must be able to swallow intact study medication capsules
* Received a single solid organ transplant at least 6 months prior to entry into the study
* The subject's parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable
* Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
* Negative pregnancy test prior to enrolment (females)
* Must agree to practice effective birth control during the study
* Stable whole blood trough levels of tacrolimus in the range of 3.5 - 15ng/mL (+/-0.5ng/mL) and clinically stable in the opinion of the Investigator
Exclusion Criteria:
* Previously received a multiple organ transplant
* Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months
* Currently receiving Rapamycin, Certican or MPA (Myfortic®)
* Chronic dysfunction of the allograft, in the opinion of the Investigator
* Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study
* The subject is pregnant or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT01294020
Study Brief:
Protocol Section:
NCT01294020