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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT00715468
Eligibility Criteria:
Inclusion Criteria:
* Received a kidney transplant at least six months
* stable graft function (no increased creatinine \> 20% in the previous 4 weeks)
* Receiving immunosuppressive regimen with stable dose of MMF for at least 4 weeks
* Immunosuppressive regimen with a dose of MMF (dose≤ 2.0 g/day) at least 4 weeks OR C0 MMF \< 1.4 µg/ml at visit 1 OR patients receiving MMF who have GI side effects
* Willing to provide written informed consent
* Women of childbearing age must have a negative pregnancy test and use a medically acceptable method of contraception throughout the treatment period;
* Over 18 years of age.
Exclusion Criteria:
* GI symptoms assumed or known not to be caused by MPA therapy;
* Acute rejection episode ≤ 4 weeks prior to study enrollment;
* Liver disease interfering with enterohepatic recirculation, such as active hepatitis B, active hepatitis C, autoimmune hepatitis and liver cirrhosis;
* Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control;
* Active bacterial, viral or fungal infection;
* Presence of psychiatric illness that in the view of the investigator would interfere with study requirements;
* Known sensitivity to the study drug;
* Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00715468
Study Brief:
Protocol Section:
NCT00715468