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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00611494
Eligibility Criteria:
Inclusion Criteria:
* recipients of liver or kidney or heart or lung or kidney/pancreas transplants
* at least 1 month post solid organ transplant
* on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
* previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
* age of 18-75 years
Exclusion Criteria:
* less than 1 month post transplant
* allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
* unwillingness or inability to give written consent
* pregnant or nursing women, or women planning to become pregnant
* patients with GI symptoms due to reasons other than related to MMF therapy
* active Post Transplant Lymphoproliferative Disease (PTLD)
* significant or uncontrolled concomitant infections or other serious medical problems
* active bacterial, viral or fungal infection
* inability to self-administer the Quality of Life questionnaires
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00611494
Study Brief:
Protocol Section:
NCT00611494