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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT00000935
Eligibility Criteria:
Inclusion Criteria
You may be eligible for this study if you:
* Are 12 years of age or older.
* Have end-stage renal disease.
* Currently receive either hemo- or peritoneal dialysis.
* Have an elevated (\> 50%) level of panel reactive antibodies (PRA level) on 3 consecutive monthly tests.
* Agree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after.
Exclusion Criteria
You will not be eligible for this study if you:
* Have received IVIG for any reason within 6 months prior to enrollment.
* Are HIV positive.
* Are Hepatitis B e-antigen/hepatitis B viral DNA-positive.
* Have selective IgA deficiency or have known antibodies to IgA.
* Are allergic to human immune globulin.
* Are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00000935
Study Brief:
Protocol Section:
NCT00000935