NCT00372229

A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	Valganciclovir CMV Prophylaxis	900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
DRUG	Valganciclovir (Pre-emptive CMV Therapy)	If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
DRUG	Ganciclovir	If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Timeline

• Start date: 2006-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2006-09-06
• Last updated: 2020-03-11
• Results posted: 2020-03-11

Locations

24 sites across 2 countries: Austria, Germany