| News From Transplant Week of March 17, 2002 / Vol. 3 No. 11 |
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Study: Thymoglobulin Results in Significant Fewer Rejections |
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A Phase II comparative study of the use of Thymoglobulin versus Simulect in high-risk kidney transplant recipients has stopped enrolling additional patients after results showed significantly fewer rejections in patients treated with Thymoglobulin, according to its manufacturer. SangStat announced that in the interim analysis, the incidence of acute kidney rejection was 2.5 times greater among patients who received industion therapy with Simulect compared to patients who received Thymoglobulin. Induction therapy is administered at the time of transplant to prevent future acute rejection of the transplanted organ. "Graft rejection is one of the principal factors determining long-term graft survival," said Dr. Daniel C. Brennan of Washington University School of Medicine in St. Louis. "In this study, Thymoglobulin was associated with less graft rejection than Simulect and had a similar safety profile." An independent Data Safety Monitoring Board voted unanimously to close the study with a total enrollment of 279 participants out of a planned 340. "The core concern is that continuing to enroll patients can't be justified when the data show the rate of acute kidney rejection is significantly lower with Thymoglobulin than Simulect," said SangStat Chairman Jean-Jacques Bienaime. Thymoglobulin,
which was introduced to the US market in 1999, is a pasteurized
anti-thymocyte rabbit immunoglobulin. Other sources: SangStat |
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