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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT00446251
Eligibility Criteria:
Inclusion Criteria:
* Age range 18 - 75, inclusive
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Outpatient status
* Patients with a Panel of Reactive Antibodies (PRA) over 10% after an 8-month trial of MMF monotherapy
* Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
* Patients with a negative purified protein derivative(PPD ) screen for tuberculosis (TB)within the last 6 months. If subject has a prior history of TB 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 and for twelve months (1 year) after completion of treatment.
* Men must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
* Liver enzymes ALT and AST less than 2 times the normal limit.
Exclusion Criteria:
* Active infection
* Receipt of live vaccine within 4 weeks prior to first infusion.
* Previous treatment with rituximab (MabThera® / Rituxan®)
* 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 hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, pregnant or breast-feeding, baseline leukopenia, white blood cell count (WBC) less than 4.0, thrombocytopenia (platelet count less than 100,000/mm) or difficult to treat anemia, a hematocrit chronically less than 32 on intravenous iron and EPO (erythropoietin) therapy, history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* History of psychiatric disorder
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00446251
Study Brief:
Protocol Section:
NCT00446251