This project was conducted as a retrospective analysis of the data of the VIPP study, a randomized multicenter trial comparing CMV prophylaxis vs. preemptive therapy with valganciclovir in CMV-positive renal allograft recipients compared in 22 centers in Germany and in 2 centers in Austria. The study included a recruitment period of 29 months, a study phase of 12 months after transplantation, and a follow-up period of 6 years.

(NCT00372229) [9, 10]. Ten SNPs were selected for TLR4, three SNPs for IFN-γ, six SNPs for IL10, nine SNPs for IL37 and two SNPs for TNF-α. Associations between these genetic variants and the occurrence of CMV infection, CMV disease, graft loss or death, rejection, infections, and leukopenia were analyzed.

According to the VIPP study protocol, CMV Disease was defined as either biopsy or clinically proven tissue invasive disease or CMV syndrome with viremia >400 copies/ml with at least one of the following signs: fever of ≥ 38°C, severe malaise (toxicity grading ≥ 3), leucopenia on 2 successive measurements separated by at least 24 hours defined as (1) a white blood cell (WBC) count of <3,500/μL or (2) a WBC decrease of >20% if the WBC count prior to development of viremia is <4,000/μL, atypical lymphocytosis of ≥5%, thrombocytopenia defined as (1) a platelet count of <100,000/μL or (2) a decrease of >20% if the platelet count prior to development of viremia is <115,000/μL, elevation of hepatic transaminases (alanine aminotransferase or aspartate aminotransferase to at least 2x ULN.

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