Preemptive therapy vs valacyclovir prophylaxis for cytomegalovirus (CMV) disease after renal transplantation

A randomised study comparing universal valacyclovir 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

ACTRN12610000015044

Enrollment

Registered

2005-06-21

Start date

2003-10-22

Completion date

2006-08-11

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The aim of the study is to compare the efficacy, safety and cost of preemptive therapy with vaganciclovir (based on quantitative PCR monitoring) versus universal 3-month prophylaxis with valacyclovir (control group, current standard in our transplant centre).

Interventions

Preemptive therapy in the case of significant positivity of PCR for CMV deoxyribonucleic acid (DNA) (>2000 copies/ml) - oral valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg twice per day until clearance of CMV viremia (negative result of PCR for CMV DNA) or for a minimum of 14 days commenced during first year post-transplant.

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 (>18 years) renal transplant recipient, donor (D) and recipient (R) pretransplant CMV serological status: D+/R-, D+/R+, D-/R+, deceased (including non-heart-beating) or living donor, informed consent

Exclusion criteria

unknown or D-/R- CMV serostatus pretransplant, allergy to acyclovir, valacyclovir, ganciclovir, and/or valganciclovir, active viral infection at the time of transplantation (including active hepatitis B infection), therapy with systemic antiviral agents <2 weeks prior to transplantation, white blood cell (WBC) count <3.5 x 10exp9/L, platelet count <100 x 10exp9/L, inability to sign informed consent, concomitant inclusion to another clinical trial

Outcome results