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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00407160
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 18-75 years.
2. Recipients of multiple kidney transplants
3. Patients with a PRA \>14% and/or a past historical PRA greater or equal to 50%.
4. Females of childbearing potential must have a negative pregnancy test prior to inclusion.
5. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Exclusion Criteria:
1. Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hCG) laboratory test.
3. Patients who are HIV positive.
4. Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00407160
Study Brief:
Protocol Section:
NCT00407160