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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT00446459
Eligibility Criteria:
Inclusion Criteria:
* Persons on the kidney transplant waiting list who are currently receiving hemodialysis
* Age range 18 - 75
* Outpatient status
* Patients with a PRA over 50% for over 6 months
* Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
* Patients with a PPD (purified protein derivative) test within the last 6 months. If subject has a prior history of TB (tuberculosis) or positive PPD, documentation of adequate treatment is required.
* Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use a medically acceptable method of contraception throughout the study.
Exclusion Criteria:
* Active infection
* History of multiple recurrent infections defined as more than 3 urinary tract infections, 2 episodes of pneumonia or 3 episodes of otitis/sinusitis in one year, or more than two dialysis line or peritoneal infections within one year. Infection with HCV (hepatitis C virus) or HBV (hepatitis B virus) or HIV (human immunodeficiency virus).
* Lack of documentation of PPD testing
* Lack of documentation of treatment of a positive PPD
* Pregnant or breast-feeding
* Baseline leukopenia, WBC \< 4.0
* Thrombocytopenia (platelet count \< 130) or difficult to treat anemia, HCT chronically \< 32 on intravenous iron and EPO (erythropoietin) therapy
* Transfusion within 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00446459
Study Brief:
Protocol Section:
NCT00446459