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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

Stanley C. Jordan^*,, Dolly Tyan, Don Stablein, Matthew McIntosh, Steve Rose^||, Ashley Vo^*, Mieko Toyoda, Connie Davis^¶, Ron Shapiro^#, Deborah Adey^**, Dawn Milliner, Ralph Graff, Robert Steiner, Gaetano Ciancio^||||, Shobah Sahney^¶¶ and Jimmy Light^##

*Renal Transplant Program, Transplant Immunology Laboratory, and Immunogenetics Laboratory, Cedars-Sinai Medical Center, UCLA School of Medicine, Los Angeles, California; Statistical Coordinating Center, The EMMMES Corporation, Rockville, Maryland;^|| NIH (NIAID) Controlled Clinical Trials in Kidney Transplantation Program, Bethesda, MD; ^¶University of Washington Medical Center, Seattle, Washington; ^#University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; **University of California–San Francisco Medical Center, San Francisco, California, Mayo Clinic, Rochester, Minnesota; St. Louis University Medical Center, St. Louis, Missouri; University of California–San Diego Medical Center, San Diego, California; ^||||University of Miami Medical Center, Miami, Florida; ^¶¶Loma Linda Medical Center, Loma Linda, California; and ^##Washington Hospital Center, Washington, DC.

Correspondence to Dr. Stanley C. Jordan, Renal Transplant Program, Cedars-Sinai Medical Center, 8635 W 3rd Street, Suite 590W, Los Angeles, CA 90048. Phone: 310-423-8282; Fax: 310-423-8208; E-mail: sjordan{at}cshs.org

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] 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.

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Copyright © 2008 by the American Society of Nephrology. Online ISSN: 1533-3450 Print ISSN: 1046-6673