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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00737659
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, between 18 to 70 years of age at the time of enrollment.
* Patient who received first or second renal transplant.
* Patients who are 0-14 days post transplant.
* Patients capable of understanding the purposes and risks of the study who signed a written informed consent to participate and to comply with the requirements of the study.
Exclusion Criteria:
* Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the study drug therapy.
* Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
* Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
* Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
* Current or historic Panel Reactive Antibody (PRA) \>50%
* Positive crossmatch (irrespective of method).
* Cold ischemia time of the graft of more than 30 hours.
* Patients who had received an investigational new drug within the last three months at the time of enrollment.
* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
* Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \<1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.
* Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
* Previous exposure to EC-MPS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00737659
Study Brief:
Protocol Section:
NCT00737659