IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Completed · Phase 3
Conditions studied: Cytomegalovirus Infections
In brief
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.
Key facts
- Study ID
- NCT00294515
- Run by
- Hoffmann-La Roche
- People needed
- 326
- Starts
- 2006-03-31
- Expected to finish
- 2009-08-31
- Last updated by the study team
- 2018-03-29
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- 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
- Uni of Michigan Medical Center — Ann Arbor, Michigan, United States
- Uni of Minnesota Medical Center; Dept of Surgery — Minneapolis, Minnesota, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- St. Barnabas Medical Center — Livingston, New Jersey, United States
- Robert Wood Johnson Uni Hospital; Anesthesia — New Brunswick, New Jersey, United States
- Wake Forest Uni School of Medicine; Section on Infectious Diseases — Winston-Salem, North Carolina, United States
- Oregon Health Sciences Uni ; Division of Nephrology — Portland, Oregon, United States
- Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery — Philadelphia, Pennsylvania, United States
- Uni of Pennslyvania Medical Center — Philadelphia, Pennsylvania, United States
- Vanderbilt Uni ; Divison of Nephrology — Nashville, Tennessee, United States
- Texas Transplant Inst. — San Antonio, Texas, United States
- Uni of Texas Health Science Center At San Antonio; Organ Transplant Program — San Antonio, Texas, United States
- Uni of Washington Medical Center; Division of Allergy & Infectious Diseases — Seattle, Washington, United States
- Royal Prince Alfred Hospital; Renal Transplant Unit — Camperdown, New South Wales, Australia
- Monash Medical Centre; Renal Transplant Unit — Clayton, Victoria, Australia
- Uni of Alabama At Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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