OVERT Study: Optimizing Valganciclovir Efficacy in Renal Transplantation
A randomised study comparing universal valganciclovir prophylaxis with quantitative polymerase chain reaction (PCR) based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients.
ass. Prof. Tomas Reischig, M.D., Ph.D.
92 participants
Jun 14, 2013
Interventional
Conditions
Summary
There are two major hypothesis to test: 1) Valganciclovir prophylaxis for cytomegalovirus infection compared to pre-emptive therapy is associated with less early acute rejection due to lower incidence of early cytomegalovirus viremia and possible immunosuppressive properties of valganciclovir. 2) Pre-emptive therapy is beneficial in long-term outcomes such as incidence of interstitial fibrosis and tubular atrophy in late biopsies due to minimizing late cytomegalovirus activation.
Eligibility
Inclusion Criteria1
- Adult renal transplant candidates, complement-dependent cytotoxicity (CDC) cross-match negative at the time of transplantation, deceased (non-heart-beating donors or dual kidney transplantation are allowed) or living (both related and unrelated, AB0 compatible or incompatible) donors with known cytomegalovirus (CMV) serology before transplantation, CMV serology: donor(D)/recipient (R) serostatus of D+/R-, D+/R+, and D-/R+, ability to sign informed consent.
Exclusion Criteria1
- Unknown pretransplantation CMV serology of the donor or recipient, D-/R- CMV serostatus, treatment of systemic viral infection within 2 weeks before transplantation except for active hepatitis B or hepatitis C infection, therapy with systemic antiviral agents within 2 weeks before transplantation except for treatment of hepatitis B (lamivudine, adefovir, entecavir), white blood cell (WBC) count <3.0 x 10exp9/L, platelet count <100 x 10exp9/L, allergy to ganciclovir, inclusion to another clinical trial, inability to provide informed consent.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Oral valganciclovir (VALCYTE, Roche) 900mg/day for 3 months (cytomegalovirus serology combinations: donor+/recipient+ and donor-/recipient+) or 6 months (cytomegalovirus serology combination: donor+/recipient-) after transplantation started within 1 week post transplant. To monitor adherence to drug intake patients will asked during each clinical visit to self report their adherence to valganciclovir use. However, no calculation of tablet return or ganciclovir plasma levels will be performed.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000554763