Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients.

Autor:	Ishida JH; Department of Medicine, Division of Nephrology, University of California, San Francisco, California, USA., Patel A; Henry Ford Transplant Institute, Detroit, Michigan, USA., Mehta AK; Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA., Gatault P; Department of Nephrology and Clinical Immunology, CHRU de Tours and EA 4245, University François Rabelais, Tours, France., McBride JM; Genentech, Inc., South San Francisco, California, USA., Burgess T; Genentech, Inc., South San Francisco, California, USA., Derby MA; Genentech, Inc., South San Francisco, California, USA., Snydman DR; Department of Medicine, Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USA., Emu B; Genentech, Inc., South San Francisco, California, USA., Feierbach B; Genentech, Inc., South San Francisco, California, USA., Fouts AE; Genentech, Inc., South San Francisco, California, USA., Maia M; Genentech, Inc., South San Francisco, California, USA., Deng R; Genentech, Inc., South San Francisco, California, USA., Rosenberger CM; Genentech, Inc., South San Francisco, California, USA., Gennaro LA; Genentech, Inc., South San Francisco, California, USA., Striano NS; Genentech, Inc., South San Francisco, California, USA., Liao XC; Genentech, Inc., South San Francisco, California, USA., Tavel JA; Genentech, Inc., South San Francisco, California, USA tavel.jorge@gene.com.
Jazyk:	angličtina
Zdroj:	Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2017 Jan 24; Vol. 61 (2). Date of Electronic Publication: 2017 Jan 24 (Print Publication: 2017).
DOI:	10.1128/AAC.01794-16
Abstrakt:	Cytomegalovirus (CMV) infection is a significant complication after kidney transplantation. We examined the ability of RG7667, a combination of two monoclonal antibodies, to prevent CMV infection in high-risk kidney transplant recipients in a randomized, double-blind, placebo-controlled trial. CMV-seronegative recipients of a kidney transplant from a CMV-seropositive donor (D+R-) were randomized to receive RG7667 (n = 60) or placebo (n = 60) at the time of transplant and 1, 4, and 8 weeks posttransplant. Patients were monitored for CMV viremia every 1 to 2 weeks posttransplant for 24 weeks. Patients who had seroconverted (D+R+) or withdrawn before dosing were excluded from the analysis (n = 4). CMV viremia occurred in 27 of 59 (45.8%) patients receiving RG7667 and 35 of 57 (61.4%) patients receiving placebo (stratum-adjusted difference, 15.3%; P = 0.100) within 12 weeks posttransplant and in 30 of 59 (50.8%) patients receiving RG7667 and 40 of 57 (70.2%) patients receiving placebo (stratum-adjusted difference, 19.3%; P = 0.040) within 24 weeks posttransplant. Median time to CMV viremia was 139 days in patients receiving RG7667 compared to 46 days in patients receiving placebo (hazard ratio, 0.53; P = 0.009). CMV disease was less common in the RG7667 than placebo group (3.4% versus 15.8%; P = 0.030). Adverse events were generally balanced between treatment groups. In high-risk kidney transplant recipients, RG7667 was well tolerated, numerically reduced the incidence of CMV infection within 12 and 24 weeks posttransplant, delayed time to CMV viremia, and was associated with less CMV disease than the placebo. (This study has been registered at ClinicalTrials.gov under registration no. NCT01753167.). (Copyright © 2017 American Society for Microbiology.)
Databáze:	MEDLINE
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