IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
- Registration Number
- NCT00294515
- Lead Sponsor
- Hoffmann-La Roche
- 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-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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valganciclovir up to 100 days Valganciclovir Valganciclovir for up to 100 days post kidney transplant Valganciclovir up to 200 days Valganciclovir Valganciclovir for up to 200 days post kidney transplant
- Primary Outcome Measures
Name Time Method Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant 12 months post-transplant Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant 24 months post-transplant Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant 6 months post-transplant Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant 9 months post-transplant Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant 18 months post-transplant Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.
Trial Locations
- Locations (80)
Uni of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
National Institute of Transplantation
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Ucsd Medical Center; Kidney Transplantation
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Uni of California San Francisco; Transplant Services
🇺🇸San Francisco, California, United States
Lifelink Healthcare Inst.
🇺🇸Tampa, Florida, United States
Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
🇺🇸Chicago, Illinois, United States
Indiana Uni Medical Center; Surgery & Microbiology/Immunology
🇺🇸Indianapolis, Indiana, United States
New England Medical Center; Division of Transplant Surgery
🇺🇸Boston, Massachusetts, United States
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