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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000554763

Acronym

OVERT

Enrollment

140

Registered

2013-05-16

Start date

2013-06-14

Completion date

2018-05-02

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results