title: Evaluation of intravenous immunoglobulin as an agent to lower allosensitization and improve transplantation in highly sensitized adult patients with end-stage renal disease: report of the NIH IG02 trial.
abstract: Reported are the reduction of anti-HLA antibody levels and improvement of transplant rates by intravenous immunoglobulin (IVIG) in a randomized, double-blind, placebo-controlled clinical trial. Between 1997 and 2000, a total of 101 adult patients with ESRD who were highly sensitized to HLA antigens (panel reactive antibody [PRA] > or =50% monthly for 3 mo) enrolled onto an NIH-sponsored trial (IG02). Patients received IVIG or placebo. Subjects received IVIG 2 g/kg monthly for 4 mo or an equivalent volume of placebo with additional infusions at 12 and 24 mo after entry if not transplanted. If transplanted, additional infusions were given monthly for 4 mo. Baseline PRA levels were similar in both groups. However, IVIG significantly reduced PRA levels in study subjects compared with placebo. Sixteen IVIG patients (35%) and eight placebo patients (17%) were transplanted. Rejection episodes occurred in 9 of 17 IVIG and 1 of 10 placebo subjects. Seven graft failures occurred (four IVIG, three placebo) among adherent patients with similar 2-yr graft survival rates (80% IVIG, 75% placebo). With a median follow-up of 2 yr after transplant, the viable transplants functioned normally with a mean +/- SEM serum creatinine of 1.68 +/- 0.28 for IVIG versus 1.28 +/- 0.13 mg/dl for placebo. Adverse events rates were similar in both groups. We conclude that IVIG is better than placebo in reducing anti-HLA antibody levels and improving transplantation rates in highly sensitized patients with ESRD. Transplant rates for highly sensitized patients with ESRD awaiting kidney transplants are improved with IVIG therapy.
authors.affiliation: Renal Transplant Program, Cedars-Sinai Medical Center, UCLA School of Medicine, 8635 W 3rd Street, Suite 590W, Los Angeles, CA 90048, USA. sjordan@cshs.org
authors.forename: Stanley C
authors.initials: SC
authors.lastname: Jordan
authors.forename: Dolly
authors.initials: D
authors.lastname: Tyan
authors.forename: Don
authors.initials: D
authors.lastname: Stablein
authors.forename: Matthew
authors.initials: M
authors.lastname: McIntosh
authors.forename: Steve
authors.initials: S
authors.lastname: Rose
authors.forename: Ashley
authors.initials: A
authors.lastname: Vo
authors.forename: Mieko
authors.initials: M
authors.lastname: Toyoda
authors.forename: Connie
authors.initials: C
authors.lastname: Davis
authors.forename: Ron
authors.initials: R
authors.lastname: Shapiro
authors.forename: Deborah
authors.initials: D
authors.lastname: Adey
authors.forename: Dawn
authors.initials: D
authors.lastname: Milliner
authors.forename: Ralph
authors.initials: R
authors.lastname: Graff
authors.forename: Robert
authors.initials: R
authors.lastname: Steiner
authors.forename: Gaetano
authors.initials: G
authors.lastname: Ciancio
authors.forename: Shobah
authors.initials: S
authors.lastname: Sahney
authors.forename: Jimmy
authors.initials: J
authors.lastname: Light
mesh_terms: D000328:Adult; D000368:Aged; D000918:Antibody Specificity; D005260:Female; D006084:Graft Rejection / Q000276:immunology* / Q000401:mortality; D006085:Graft Survival / Q000276:immunology*; D006680:HLA Antigens / Q000276:immunology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007518:Isoantibodies / Q000097:blood; D007676:Kidney Failure, Chronic / Q000276:immunology* / Q000401:mortality; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D006680:HLA Antigens; D016756:Immunoglobulins, Intravenous; D007518:Isoantibodies