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Abstract: SA-OR60

Reduction of Renal Graft Fibrosis with Valganciclovir Prophylaxis for Cytomegalovirus Prevention Compared to Preemptive Therapy: Long-Term Outcomes of Randomized Controlled Trial (OVERT Study)

Session Information

Category: Transplantation

  • 2102 Transplantation: Clinical


  • Reischig, Tomas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Vlas, Tomas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Drenko, Petr, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Kielberger, Lukas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Richtrova, Pavlina, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia

Prevention of cytomegalovirus (CMV) infection including CMV indirect effects is essential in kidney transplantation. The 12-month results of OVERT Study showed less subclinical rejection and a trend toward lower incidence of acute rejection in recipients receiving valganciclovir prophylaxis compared to preemptive therapy. Here we report long-term results of OVERT Study.


This was an open-label, single-center, randomized clinical trial of valganciclovir prophylaxis vs preemptive therapy in 140 kidney transplant recipients recruited between June 2013 and May 2018. CMV-seronegative recipients with negative donors (D-R-) were excluded. Patients were randomized 1:1 to receive either valganciclovir prophylaxis for 3 months (or 6 months in D+R-) (n=70) or preemptive valganciclovir for significant CMV DNAemia detected in predefined assessments through month 24 (n=70). The primary outcome was the incidence of moderate to severe interstitial fibrosis and tubular atrophy (IFTA) in protocol biopsy at 3 years. Key secondary outcomes included acute rejection, CMV disease and DNAemia, patient and graft survival.


Among the 127 patients who had a protocol biopsy specimen available at 3 years, 5 (8%) of 66 patients in the prophylaxis group and 14 (23%) of 61 patients in the preemptive group had moderate to severe IFTA (P=0.015). At 3 years the incidence of acute rejection was lower with valganciclovir prophylaxis (13% vs 36%, P=0.052). In spite of 5 (7%) additional patients with CMV DNAemia after month 12 in the prophylaxis group in contrast to none in the preemptive group (P=0.025) the cumulative incidence at 2 years remained lower with prophylaxis (51% vs 75%, P<0.001). Both regimens prevented CMV disease (6% vs 4%, P=0.733). While the 4-year graft survival was comparable (96% vs 93%, P=0.460) patient survival was improved in the prophylaxis group (100% vs 94%, P=0.042).


Among kidney transplant recipients, the use of valganciclovir prophylaxis, compared with preemptive therapy, led to less severe IFTA at 3 years after transplantation.