Date: Saturday, May 2, 2015
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Exhibit Hall E
Greater than 90% of all kidney transplants(KTx) today receive an induction agent. The choice of a depleting or non-depleting agent is center specific. Alemtuzumab (Alem), a humanized monoclonal antibody specific to CD52, is one of the newest induction agents to be used in kidney transplant and leads to profound T-cell depletion.
At our institution, ATG is the induction agent of choice for high-risk pts, which includes African Americans (AAs). African Americans are considered to be at high risk for rejection and have been shown to have poorer outcomes when compared to non-AA recipients.
The purpose of this study is to determine the safety and efficacy of an Alem induction regimen compared to an ATG induction regimen in high-risk, non-sensitized AA renal transplant recipients.
A prospective, randomized study of Alem versus ATG as induction therapy is currently enrolling pts. After informed consent is obtained, pts are randomized to either ATG 1.5 mg/kg for 5 doses or to Alem 30 mg once pre-op. Patients will be included if they are AA and receiving a living or deceased donor kidney. Highly sensitized pts will be excluded from the study (PRA > 10%, ABO incompatible or PXM with living donor). All pts are maintained on tacrolimus and mycophenolate. In addition, a steroid avoidance regimen is utilized which stops steroids by day 6. Patients will be followed during their clinic visits for one year after transplant in order to assess for the primary endpoint of biopsy proven acute rejection (BPAR).
Twelve pts have been enrolled to date with 4 pts completing the 1 yr follow-up and 1 pt lost to follow-up. Seven pts have been randomized to the ATG group and 5 pts to the Alem group. Of these 28.6% (2 of 7) of the ATG pts have had BPAR while 0% (0 of 5) of the Alem have had BPAR. One pt in the Alem group was leukopenic on 4 of 12 study visits, but did not receive filgrastim, while no pts in the ATG group experienced leukopenia. One pt in the ATG group required therapy with an ESA compared to no pts in the Alem group.
At this time, preliminary results of the study suggest there is more BPAR seen in the ATG group; however, this is limited by the small sample size. In addition, there have been no clinically significant safety concerns.
To cite this abstract in AMA style:Janusek M, Patel S, Galen K, West-Thilke P, Benedetti E, Thielke J. A Comparison of Alemtuzumab and Antithymocyte Globulin Induction in High-Risk, Non-Sensitized African American Renal Transplant Recipients [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/a-comparison-of-alemtuzumab-and-antithymocyte-globulin-induction-in-high-risk-non-sensitized-african-american-renal-transplant-recipients/. Accessed July 23, 2019.
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