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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). However, many patients do not receive this treatment due to immune sensitization to HLA antigens. IVIG has been shown to somewhat reduce anti-HLA antibody activity. By blocking this activity, IVIG may make transplants more feasible and increase graft survival in transplant recipients.

Patients are randomized to receive IV infusion of either 2 g/kg (maximum dose 180 g) IVIG 10% S/D (Gamimune-N, 10%, manufactured by Bayer) or placebo (0.1% human albumin, manufactured by Bayer) at time of dialy...

Gender

ALL

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.