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

PHASE3CompletedINTERVENTIONAL
Enrollment

299

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Cytomegalovirus Infections
Interventions
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.

Trial Locations (24)

1090

Vienna

6020

Innsbruck

12203

Berlin

13353

Berlin

20246

Hamburg

23562

Lübeck

28205

Bremen

30625

Hanover

34346

Hannoversch Münden

40225

Düsseldorf

45122

Essen

48149

Münster

50937

Cologne

52057

Aachen

60596

Frankfurt

72076

Tübingen

79106

Freiburg im Breisgau

81377

München

81675

München

91054

Erlangen

93053

Regensburg

97080

Würzburg

07747

Jena

04103

Leipzig

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00372229 - A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation | Biotech Hunter | Biotech Hunter