IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

This study has been completed.

First Received: February 21, 2006 Last Updated: January 15, 2010 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00294515

Purpose

This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Cytomegalovirus Infections	Drug: valganciclovir [Valcyte]	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind Study to Compare the Effect of up to 100 Days, and up to 200 Days, of Treatment With Valcyte (Valganciclovir) on Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Valganciclovir hydrochloride Valganciclovir

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients who develop CMV disease [ Time Frame: First 52 weeks post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients who develop CMV disease;time to CMV disease;CMV viremia;seroconversion;acute rejection;survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse events; laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:

326

Arms	Assigned Interventions
1: Experimental	Drug: valganciclovir [Valcyte] 900mg po daily for 100 days
2: Active Comparator	Drug: valganciclovir [Valcyte] 900mg po daily for 200 days

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

>= 16 years of age;
CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor;
adequate hematological and renal function;
patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication

Exclusion Criteria:

CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening;
multi-organ transplant recipient;
hepatitis B, hepatitis C or HIV positive;
women who are pregnant or lactating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294515

Show 80 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NT18435
Study First Received:	February 21, 2006
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00294515 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Virus Diseases
Anti-Infective Agents
Valganciclovir
Therapeutic Uses
Cytomegalovirus Infections
Ganciclovir

DNA Virus Infections
Infection
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010