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This study demonstrated that SRL-based therapy was efficacious in high-risk renal allograft recipients in the first year after transplant, providing equivalent efficacy with CsA or TAC, similar graft survival, low biopsy-confirmed acute rejection rates, excellent renal function, and an acceptable safety profile.

This multicenter, open-label study compared the efficacy, safety, and pharmacokinetic parameters of sirolimus (rapamycin) tablet and liquid formulations for prevention of efficacy failure. A total of 477 renal allograft recipients were randomly assigned (1:1) to receive either tablet or solution formulations of sirolimus for 12 months, plus cyclosporine (CsA) and steroids. Pharmacokinetic parameters were analyzed based on trough concentrations and 24-hour pharmacokinetic profiles. There were no significant differences in efficacy failure at 3 or 12 months between tablet and solution groups. Graft survival, patient survival, rate of first biopsy-confirmed acute rejection, time to and severity of acute rejection, and laboratory parameters were not significantly different between groups. Mean steady-state sirolimus and CsA pharmacokinetic parameters on days 30 and 90 were not significantly different by formulation, except for longer sirolimus t(max) after tablet administration. Multivariate logistic regression analysis indicated that low sirolimus C(min,TN) and more human leukocyte antigen mismatches were predictors of acute rejection. The tablet and solution formulations of sirolimus demonstrated therapeutic equivalence.

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The present study evaluated whether the addition of sirolimus to a cyclosporine (CyA)/prednisone (Pred) regimen mitigated the greater proclivity to acute rejection episodes and graft loss characteristic of African-American renal transplant recipients. Using Kaplan-Meier and log-rank tests, African-American renal transplant recipients treated with either CyA/Pred (n = 90) or sirolimus/CyA/Pred (n = 47) were compared with 120 Caucasian patients treated with sirolimus/CyA/Pred for 2-year rates of patient and graft survival as well as acute rejection episodes. Mean laboratory values were compared using analysis of variance and F-tests. Addition of sirolimus to the CyA/Pred regimen reduced the incidence of acute rejection episodes in African-Americans from 43.3% to 19.2% (P = 0.004), a value similar to Caucasian patients. The 97.9% 2-year graft survival rate among 47 African-American patients treated with sirolimus/CyA/Pred was significantly higher than the 85.6% rate shown among the 90 CyA/Pred-treated African-American transplant recipients (P = 0.0479) and similar to that in Caucasians. The 95.7% patient survival rate among the African-American sirolimus/CyA/Pred group was similar to the 97.8% rate in the African-American CyA/Pred cohort. Interestingly, there was no evident toxicity from the addition of sirolimus. The addition of sirolimus to a CyA-based regimen reduced acute rejection episodes and graft loss experienced by African-American renal transplant recipients.

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Antibodies specific for recipient red cell antigens have been demonstrated in patients who receive organs from ABO unmatched donors. In some cases, severe but self-limited hemolysis has been associated with the development of posttransplantation antibodies. We report a case in which an A2 recipient of a kidney from a group O donor formed anti-A1 antibody which reacted with homologous red cells. The patient developed a delayed hemolytic transfusion reaction. A radiochromium survival study revealed decreased survival of A1 red cells. A broader specificity of the antibody was not shown during follow-up. The anti-A1 was not detected in a sample tested 6 months after the initial study. It is probable that the anti-A1 noted in this case was formed by passenger lymphocytes. A2 patients who develop anti-A1 after renal transplantation should be transfused with red cells negative for A1.