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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00189150
Eligibility Criteria:
Inclusion Criteria:
The subject must be able to give informed consent for the study. Stable renal or cardiac transplant patients age 18 years and older. Patients must not have had an acute rejection episode within the previous 30 days of the 1st PK study.
Renal transplant patients with serum creatinine \< 2 mg/dL and with change in serum creatinine \< 25% within the 2 weeks prior to the 1st PK study.
Renal and cardiac transplant patients receiving VGCV for prophylaxis of CMV while concomitantly receiving MMF.
Stable MMF dose: the dose of MMF must not have been adjusted within 1 week of the 1st PK study and must be the same during the 2nd PK study Stable renal function during the study period (change in serum creatinine \< 25%)
Exclusion Criteria:
Patients who are not prescribed MMF maintenance therapy or are receiving Myfortic.
Patients who do not require VGCV prophylaxis (CMV negative recipients of CMV negative donor organs).
Patients who have their MMF doses adjusted either \< 1 week before the 1st scheduled PK study or anytime during the study period.
Patients whose serum creatinine changes by \> 25% within 2 weeks prior to study initiation.
Patients whose hematocrit \< 28%. Patients who received other organ transplants in addition to a kidney or heart. Patients who are pregnant or breast-feeding. Patients prescribed bile acids, bile acid sequestrants, potassium binding resins, or magnesium/aluminum-containing antacids.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00189150
Study Brief:
Protocol Section:
NCT00189150