An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens
End-Stage Renal Disease, Kidney Transplantation
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
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.
Sites / Locations
- Ann Limberger
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intravenous Immune Globulin (Human)
Intravenous Immune Globulin (Human) Placebo