A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00372229

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Infections	Drug: valganciclovir [Valcyte] Drug: Pre-emptive therapy	Phase III

MedlinePlus related topics: Cytomegalovirus Infections Kidney Transplantation

Drug Information available for: Valganciclovir Valganciclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-Emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with active CMV infection, or CMV disease. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Urine proteomic pattern [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Time to graft loss [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2015

Arms	Assigned Interventions
1: Experimental	Drug: valganciclovir [Valcyte] 900mg po for 100 days
2: Active Comparator	Drug: Pre-emptive therapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

primary or secondary renal allograft within preceding 14 days;
IgG seropositive for CMV;
receiving immunosuppressive therapy.

Exclusion Criteria:

active CMV infection;
current/history of malignancy;
acute steroid resistant rejection episode since transplantation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372229

Contacts

Contact: Please reference Study ID Number: ML19313	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Austria
	Recruiting
INNSBRUCK, Austria, 6020
	Recruiting
WIEN, Austria, 1090
Germany
	Recruiting
AACHEN, Germany, 52057
	Recruiting
BERLIN, Germany, 13353
	Recruiting
DÜSSELDORF, Germany, 40225
	Recruiting
ERLANGEN, Germany, 91054
	Recruiting
ESSEN, Germany, 45122
	Recruiting
FRANKFURT AM MAIN, Germany, 60590
	Terminated
FREIBURG, Germany, 79106
	Recruiting
HANNOVER, Germany, 30625
	Recruiting
HANNOVER, Germany, 34346
	Recruiting
JENA, Germany, 07740
	Recruiting
BREMEN, Germany, 28177
	Recruiting
LÜBECK, Germany, 23538
	Recruiting
MÜNCHEN, Germany, 81377
	Recruiting
MÜNSTER, Germany, 48149
	Recruiting
REGENSBURG, Germany, 93053
	Recruiting
TÜBINGEN, Germany, 72076
	Recruiting
WÜRZBURG, Germany, 97080
	Recruiting
HAMBURG, Germany, 20246
	Recruiting
MÜNCHEN, Germany, 81675
	Recruiting
KOELN, Germany, 50931
	Recruiting
BERLIN, Germany, 12203
	Recruiting
LEIPZIG, Germany, 04103

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19313
Study First Received:	September 5, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00372229
Health Authority:	Germany: BefArM Bundesinstitut fur Arzneimittel und Medizinproduckte

Study placed in the following topic categories:

Virus Diseases
Valganciclovir
Cytomegalovirus Infections
DNA Virus Infections

Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009