Status:
COMPLETED
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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-ris...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
March 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2009
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00294515
Start Date
March 31 2006
End Date
August 31 2009
Last Update
March 29 2018
Active Locations (80)
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1
Uni of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
National Institute of Transplantation
Los Angeles, California, United States, 90057
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
Ucsd Medical Center; Kidney Transplantation
San Diego, California, United States, 92103-8401