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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT00586716
Eligibility Criteria:
Inclusion Criteria:
* 12 years of age or older
* diagnosed with end stage renal disease
* currently receiving either hemodialysis or peritoneal dialysis
* active on the kidney or kidney/pancreas transplant list
* medical clearance of the kidney donor if live related transplant
* elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list
Exclusion Criteria:
* received IVIG within 6 months prior to enrollment
* HIV positive
* Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
* Selective IgA deficiency or known antibodies to IgA
* Allergy to human immune globulin
* Pregnant or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
80 Years
Study:
NCT00586716
Study Brief:
Protocol Section:
NCT00586716