Intravenous Gammaglobulin (IVIG): A Novel Approach to Improve Transplant Rates and Outcomes in Highly HLA-Sensitized Patients

S. C. Jordan; A. A. Vo; A. Peng; M. Toyoda; D. Tyan

Disclosures

American Journal of Transplantation. 2006;6(3):459-466. 

In This Article

The NIH IGO2 Study

From 1997 to 2000, the NIH conducted the IGO2 study that was a controlled clinical, multi-center, double blinded trial of IVIG versus placebo in highly sensitized patients awaiting kidney transplantation. The study was designed to determine whether IVIG could reduce PRA levels and improve rates of transplantation without concomitantly increasing the risk of graft loss in this difficult to transplant group. This study represents the only controlled clinical trial of a desensitization therapy. Data from this trial were recently published.[14] Briefly, IVIG was superior to placebo in reducing anti-HLA antibody levels (p = 0.004, IVIG vs. placebo) and improving rates of transplantation. The 3-year follow-up shows the predicted mean time to transplantation was 4.8 years in the IVIG group versus 10.3 years in the placebo group (p = 0.02). With a median follow-up of 3 years post-transplant, the viable transplants functioned normally with a mean (±SE) serum creatinine of 1.68 ± 0.28 (IVIG) versus 1.28 ± 0.13 mg/dL for placebo (p = 0.29). Allograft survival was also superior in the IVIG group at 3 years. From this multi-center, double-blinded, placebo controlled trial we concluded that IVIG is superior to placebo in reducing anti-HLA antibody levels and improving transplantation rates in highly sensitized ESRD patients. Although more AR episodes were seen in the IVIG treatment group, the 2-year allograft survival and mean serum creatinines were similar to the placebo group. Transplant rates for highly sensitized ESRD patients awaiting kidney transplants were improved with IVIG therapy.

Thus, it appears that IVIG alone offers significant benefits in desensitizing highly HLA-sensitized patients and improves the rates of transplantation in this difficult to transplant group without patients experiencing excessive allograft loss.

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