An open-label, randomized, parallel-group, multicenter, non-inferiority trial comparing the effectiveness and safety of an immuno-guided strategy versus a viremia-guided strategy for the prevention of cytomegalovirus infection in seropositive kidney transplant recipients.

Fundación para la Investigación Biomedica del Hospital 12 de Octubre0 个研究点开始时间: 2013年5月16日最近更新: 2017年4月18日

适应症

试验速览

暂无简介。

•-Participant is aged 18 years or older.
•-Participant is willing and able to give informed consent (IC) for participation in the study.
•-Presence of end-stage renal disease (ESRD) of any cause undergoing KT regardless of donor type (live, heart-beating or non-heart-beating).
•- Recipient of intermediate risk, ie, seropositive for CMV (R +) (presence of a positive serology for CMV in the pre-transplant evaluation (performed at least 6 months prior to inclusion in the study) and not subject to any depletor treatment of lymphocytes.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 354
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 354

•The participant may not enter the study if ANY of the following apply:
•- Inability or unwillingness of individual or legal guardian/representative to give written IC for participation in the study.
•- Formal contraindication for receiving antiviral drugs (ganciclovir or valganciclovir): pregnancy or use of unreliable birth control methods; breastfeeding; preexisting or sustained neutropenia (<0.50 x 109 cells/L); creatinine clearance (CrCl) <10 mL/min; or known hypersensitivity to GCV, VGCV or aciclovir.
•- Participant undergoing a simultaneous double SOT (pancreas-kidney or liver-kidney).
•- Participant who has underwent a previous SOT or allo-HSCT.
•- Administration of induction therapy after transplantation with lymphocyte-depleting drugs (ATG or anti-CD3 monoclonal antibodies [muromonab]).
•- Infection by the human immunodeficiency virus (HIV), as assessed by serologic testing in the pre-transplant evaluation (performed at least within 6 months prior to study entry).
•- Participation in another clinical drug trial.

发起方

Fundación para la Investigación Biomedica del Hospital 12 de Octubre