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, Jimmy Light

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320 Scopus citations

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] ≥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.

Original languageEnglish (US)
Pages (from-to)3256-3262
Number of pages7
JournalJournal of the American Society of Nephrology
Volume15
Issue number12
DOIs
StatePublished - Dec 1 2004

ASJC Scopus subject areas

  • Nephrology

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    Jordan, S. C., Tyan, D., Stablein, D., McIntosh, M., Rose, S., Vo, A., Toyoda, M., Davis, C., Shapiro, R., Adey, D., Milliner, D., Graff, R., Steiner, R., Ciancio, G., Sahney, S., & Light, J. (2004). 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. Journal of the American Society of Nephrology, 15(12), 3256-3262. https://doi.org/10.1097/01.ASN.0000145878.92906.9F