299
Participants
Start Date
May 31, 2006
Primary Completion Date
October 31, 2015
Study Completion Date
October 31, 2015
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.
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.
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.
Vienna
Innsbruck
Berlin
Berlin
Hamburg
Lübeck
Bremen
Hanover
Hannoversch Münden
Düsseldorf
Essen
Münster
Cologne
Aachen
Frankfurt
Tübingen
Freiburg im Breisgau
München
München
Erlangen
Regensburg
Würzburg
Jena
Leipzig
Hoffmann-La Roche
INDUSTRY