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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT00352092
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years
* Male/female recipients
* All ethnic groups
* Negative pregnancy test
* Practicing an acceptable form of birth control
* Signing informed consent
Exclusion Criteria:
* Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
* Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
* Liver, heart, pancreas or small bowel transplant recipient
* Fasting total cholesterol \>300 mg/dL and fasting triglycerides \>400 mg/dL
* Baseline WBC count \<3000/cu.mm
* Baseline platelet count \<100,000/cu.mm
* Known or suspected malignancy within previous 3 years, (Patients with squamous cell and basal skin cancer are not excluded)
* Active systemic infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00352092
Study Brief:
Protocol Section:
NCT00352092