Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses. Issue 10 (18th May 2015)

• Record Type: Journal Article
• Authors: Tedesco‐ Silva, H.; Felipe, C.; Ferreira, A.; Cristelli, M.; Oliveira, N.; Sandes‐Freitas, T.; Aguiar, W.; Campos, E.; Gerbase‐DeLima, M.; Franco, M.; Medina‐Pestana, J.
• Is Part Of: American journal of transplantation. Volume 15:Issue 10(2015:Oct.)
• Page Start: 2655
• Page End: 2664
• Publication Date: 2015-05-18
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.13327
• Languages: English
• ISSNs: 1600-6135

Abstract

<abstract abstract-type="main" xml:lang="en"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ajt13327-sec-0001" sec-type="section"> <p>This study compared the incidence of CMV infection/disease in <italic>de novo</italic> kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone (r‐ATG/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n = 101). The primary end‐point was the incidence of first CMV infection/disease in the intention‐to‐treat population at 12 months. Patients treated with r‐ATG/EVR showed a 90% proportional reduction (4.7% vs. 37.6%, HR 0.10, 95% CI 0.037–0.29; p < 0.001), while those treated with BAS/EVR showed a 75% proportional reduction (10.8% vs. 37.6%, HR 0.25, 95% CI 0.13–0.48; p < 0.001) in the incidence of CMV infection/disease compared to BAS/MPS. There were no differences in the incidence of acute rejection (9.4 vs. 18.6 vs. 15.8%, p = 0.403), wound‐healing complications, delayed graft function, and proteinuria. Mean estimated glomerular filtration rate was lower in BAS/EVR (65.7 ± 21.8 vs. 60.6 ± 20.9 vs. 69.5 ± 21.5 ml/min, p = 0.021). In <italic>de novo</italic> kidney transplant recipients receiving no pharmacological CMV prophylaxis, reduced‐dose tacrolimus and everolimus was associated with a significant reduction in the incidence of CMV infection/disease compared to standard tacrolimus dose and mycophenolate (<ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> NCT01354301).</p> </sec> </abstract>