Abstract: TH-PO0924
Immune Monitoring-Guided Cytomegalovirus Surveillance in Preemptive Therapy After Kidney Transplantation: A Randomized Clinical Trial
Session Information
- Transplantation: Clinical - Glomerular Diseases, Infections, and Rejection
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Reischig, Tomas, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
- Vlas, Tomas, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
- Drenko, Petr, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
- Kielberger, Lukas, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
- Maule, David, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
- Bouda, Mirko, Charles University, Faculty of Medicine in Pilsen, Teaching Hospital, Pilsen, Czechia
Background
Preemptive therapy for cytomegalovirus (CMV) prevention requires weekly monitoring of CMV DNAemia. The use of CMV-specific cell-mediated immunity (CMV-CMI) may individualize CMV monitoring to guide preemptive therapy.
Methods
In open-label, single-center, randomized trial, kidney transplant recipients were enrolled if they were CMV-seronegative with seropositive donor (D+R-) or CMV-seropositive (R+) between May 2018 and October 2024. Patients were randomized in a 1:1 ratio to immune-guided monitoring based on CMV-CMI (QuantiFERON-CMV) assessed at 3 weeks after transplantation or to standard monitoring by weekly CMV PCR for 4 months. In immune-guided group, CMV PCR was performed every 4 weeks between 1 and 4 months if CMV-CMI assay was positive. Preemptive valganciclovir therapy was initiated after detection of CMV DNAemia (≥1000 IU/mL). The primary outcome was the incidence of significant CMV DNAemia (≥2000 IU/mL) at 12 months.
Results
Overall, 189 patients were randomized (97 in the immune-guided group and 92 in the standard group), of whom 60 immune-guided patients (62%; D+R-, 0%; R+, 74%) had positive CMV-CMI test and were scheduled to less frequent monitoring. The incidence of significant CMV DNAemia was comparable in both groups (49% vs 47%, P=0.838) including sub-analysis in R+ patients (44% vs 41%, P=0.766). Both regimens prevented CMV disease (3% vs 2%, P=0.712), however a numerically higher incidence of high-grade (≥10,000 IU/mL) CMV DNAemia was observed in immune-guided group (28% vs 19%, P=0.147). In immune-guided group, 9 patients received rescue valganciclovir for high-grade CMV DNAemia detected outside the specified monitoring. There were no differences in acute rejection and graft survival.
Conclusion
Compared to standard 4-month weekly monitoring, the use of CMV-CMI to guide CMV surveillance in preemptive therapy resulted in similar incidence of significant CMV DNAemia with very low CMV disease rates and enabled less frequent monitoring in majority of R+ patients.
Funding
- Government Support – Non-U.S.