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90. Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study

Author

Berger, S. P., Sommerer, C., Witzke, O., Tedesco, H., Chadban, S., Mulgaonkar, S., Qazi, Y., de Fijter, J. W., Oppenheimer, F., Cruzado, J. M., Watarai, Y., Massari, Pietro, Legendre, C., Citterio, Franco, Henry, M., Srinivas, T. R., Vincenti, F., Gutierrez, M. P. H., Marti, A. M., Bernhardt, P., Pascual, J., Massari P., Citterio F. (ORCID:0000-0003-0489-6337), Berger, S. P., Sommerer, C., Witzke, O., Tedesco, H., Chadban, S., Mulgaonkar, S., Qazi, Y., de Fijter, J. W., Oppenheimer, F., Cruzado, J. M., Watarai, Y., Massari, Pietro, Legendre, C., Citterio, Franco, Henry, M., Srinivas, T. R., Vincenti, F., Gutierrez, M. P. H., Marti, A. M., Bernhardt, P., Pascual, J., Massari P., and Citterio F. (ORCID:0000-0003-0489-6337)

Abstract

TRANSFORM (TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen) was a 24-month, prospective, open-label trial in 2037 de novo renal transplant recipients randomized (1:1) within 24 hours of transplantation to receive everolimus (EVR) with reduced-exposure calcineurin inhibitor (EVR + rCNI) or mycophenolate with standard-exposure CNI. Consistent with previously reported 12-month findings, noninferiority of the EVR + rCNI regimen for the primary endpoint of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) <50 mL/min per 1.73 m2 was achieved at month 24 (47.9% vs 43.7%; difference = 4.2%; 95% confidence interval = −0.3, 8.7; P =.006). Mean eGFR was stable up to month 24 (52.6 vs 54.9 mL/min per 1.73 m2) in both arms. The incidence of de novo donor-specific antibodies (dnDSA) was lower in the EVR + rCNI arm (12.3% vs 17.6%) among on-treatment patients. Although discontinuation rates due to adverse events were higher with EVR + rCNI (27.2% vs 15.0%), rates of cytomegalovirus (2.8% vs 13.5%) and BK virus (5.8% vs 10.3%) infections were lower. Cytomegalovirus infection rates were significantly lower with EVR + rCNI even in the D+/R− high-risk group (P <.0001). In conclusion, the EVR + rCNI regimen offers comparable efficacy and graft function with low tBPAR and dnDSA rates and significantly lower incidence of viral infections relative to standard-of-care up to 24 months. Clinicaltrials.gov number: NCT01950819.

Published
2019

93. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation

Author

Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., Citterio F. (ORCID:0000-0003-0489-6337), Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., and Citterio F. (ORCID:0000-0003-0489-6337)

Abstract

Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR,50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin. Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, 21.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, 21.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events. Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.

Published
2018

99. Genetic peculiarities of the wild boar in Italy

Author

Lancioni, Hovirag, Vercillo, Francesca, Capodiferro, MARCO ROSARIO, Cardinali, Irene, Sabino, M, Biagetti, M, Vincenti, F, Sebastiani, Carla, Dionigi, F, Iacolina, L, Rizzi, E, Olivieri, A, Sergiacomi, U, Scandura, M, Torroni, Antonio, Ragni, Bernardino, and Achilli, Alessandro

Subjects
mitochondrial DNA, Phylogeny, mitochondrial DNA, Phylogeny
Published
2014

100. Altered balance between effector T cells and FOXP3+HELIOS+regulatory T cells after thymoglobulin induction in kidney transplant recipients

Author

Tang, Q, Leung, J, Melli, K, Lay, K, Chuu, EL, Liu, W, Bluestone, JA, Kang, SM, Peddi, VR, and Vincenti, F

Abstract

This study examined the effect of thymoglobulin induction therapy on leukocyte population dynamics in kidney transplant patients. Patients receiving standard immunosuppression were compared with those who received additional thymoglobulin at the time of kidney transplantation. Thymoglobulin induction led to an immediate and significant decrease of all T cells and NK cells, but not B cells or monocytes. CD8+T cells recovered to near pretransplant level by 4 weeks post-transplant. CD4+T cells remained at less than 30% of pretransplant level for the entire study period of 78 weeks. Both CD4+and CD8+T cells showed reduced cytokine production after recovery. Deletion of CD4+FOXP3+HELIOS+regulatory T cells (Tregs) was less profound than that of CD4+FOXP3-cells, thus the relative percentage of Tregs elevated significantly when compared with pretransplant levels in thymoglobulin-treated patients. In contrast, the percentages of Tregs and their expression of FOXP3 in the standard immunosuppression group decreased steadily and by 12 weeks after transplant the average percentage of Tregs was 56% of the pretransplant level. Thus, thymoglobulin-induced deletion of T cells led to significant and long-lasting alterations of the T-cell compartment characterized by a preservation of Tregs and long-lasting reduction in CD4+, and potentially pathogenic, T cells. © 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.

Published
2012
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